Sud Full 601f
Sud Full 601f
Practice Guideline
Management of
Substance Use Disorder s (SUD)
August, 2009
VA/DoD Evidence Based Practice
VA/DoD CLINICAL PRACTICE GUIDELINE FOR MANAGEMENT
OF
Prepared by:
Working Group
QUALIFYING STATEMENTS
The Department of Veterans Affairs (VA) and The Department of Defense (DoD) guidelines are based
on the best information available at the time of publication. They are designed to provide information
and assist in decision-making. They are not intended to define a standard of care and should not be
construed as one. Also, they should not be interpreted as prescribing an exclusive course of
management.
Variations in practice will inevitably and appropriately occur when providers take into account the
needs of individual patients, available resources, and limitations unique to an institution or type of
practice. Every healthcare professional making use of these guidelines is responsible for evaluating
the appropriateness of applying them in any particular clinical situation.
Page
Introduction 1
Guideline Update Working Group 4
Definitions 6
Algorithms and Annotations 8
Module A: Screening and Initial Assessment for Substance Use 10
Module B: Management of SUD in Specialty SUD Care 24
Module C: Management of SUD in (Primary) General Healthcare 39
Module P: Addiction‐Focused Pharmacotherapy 54
Module S: Stabilization and Withdrawal Management 74
Appendices
Appendix A: Guideline Development Process 91
Appendix B: Screening and Assessment Tools 98
Appendix C: Addiction‐Focused Psychosocial Interventions 122
Appendix D: Department of Defense Instruction (DoDI 1010.6) 133
Appendix E: Sedative‐Hypnotic Equivalent Oral Doses 135
Appendix F: Acronym List 136
Appendix G: Participant List 137
Appendix H: Bibliography 142
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
INTRODUCTION
The Clinical Practice Guideline for the Management of Substance Use Disorders (SUD) was
developed under the auspices of the Veterans Health Administration (VHA) and the Department of
Defense (DoD) pursuant to directives from the Department of Veterans Affairs (VA). VHA and DoD
define clinical practice guidelines as:
BACKGROUND
Substance use disorders (SUD) constitute a major public health problem with a substantial impact on
health, societal costs, and personal consequences.
• SUD in the VA population: In 2007 fiscal year, over 375,000 VA patients had a substance
use disorder diagnosis and nearly 500,000 additional patients had a nicotine dependence
diagnosis in the absence of other substance use disorders. (Dalton A, Saweikis M, McKellar
JD: Health Services for VA Substance Use Disorder Patients: Comparison of Utilization
Fiscal Years 2005, 2004, 2003 and 2002. Palo Alto, CA, Program Evaluation and Resource
Center, 2004.)
• SUD in the DoD population: The substantial negative consequences of alcohol use on the
work performance, health, and social relationships of military personnel have been a
continuing concern assessed in DoD surveys. In 2005, 8.1 percent of military personnel
anonymously responding to a survey reported one or more serious consequences associated
with alcohol use during the year, a decline from 9.6 percent in 2002. Using AUDIT criteria,
2.9 percent of respondents were estimated to be highly likely to be dependent on alcohol in
2005. (Bray RM, Hourani LL, Olmsted KLR, et al. 2005 Department of Defense Survey of
Health Related Behaviors Among Active Duty Military Personnel. Research Triangle Park,
NC: Research Triangle International, December, 2006.) Available at:
http://www.ha.osd.mil/special_reports/2005_Health_Behaviors_Survey_1-07.pdf
Target population
This guideline applies to adult patients with substance use conditions treated in any VA/DoD
clinical setting, including patients who have both substance use and other health conditions; and
patients with any level of severity ranging from hazardous and problematic use to substance use
disorders.
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For Management of Substance Use Disorders
Audiences
The guideline is relevant to all healthcare professionals providing or directing treatment services to
patients with substance use conditions in any VA/DoD healthcare setting, including specialty SUD
care, and both general and mental healthcare settings.
Related Guideines
Tobacco use should be addressed in all patients and is a major cause of morbidity and mortality among
patients with non-nicotine SUDs. For management of nicotine dependence, refer to the Clinical
Practice Guideline: Treating Tobacco Use & Dependence: 2008 Update from the U.S. Department of
Health and Human Services available at:
http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf and the VA/DoD Clinical
Practice Guideline for Management of Tobacco Use.
Introduction - Page 2
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
For management of patients presenting with SUDs and depression, refer to the VA/DoD Clinical
Practice Guideline for the Management of Major Depressive Disorder (MDD). For management of
prescribed opioids for chronic pain, refer to the VA/DoD Clinical Practice Guideline for the
Management of Chronic Opioid Therapy. Additional recommendations for patients with co-occurring
conditions may be found in the VA/DoD Clinical Practice Guideline for the Management of Post
Traumatic Stress (ASD and PTSD).
Development Process
The development process of this guideline follows a systematic approach described in “Guideline-for-
Guideline,” an internal working document of VA/DoD Evidence-Based Practice Working Group.
The literature was critically analyzed and evidence was graded using a standardized format. The
evidence rating system for this document is based on the system used by the U.S. Preventative Services
Task Force (see Appendix A – Development Process).
If evidence exists, the discussion of the recommendations includes an evidence table that indentifies
the studies that have been considered, the quality of the evidence, and the rating of the strength of the
recommendation [SR]. The strength of recommendation, based on the level of the evidence and graded
using the USPSTF rating system (see Table: Evidence Rating System), is presented in brackets
following each guideline recommendation. Recommendations that are based on consensus of the
Working Group include a discussion of expert opinion on the given topic. No [SR] is presented for
these recommendations. A complete bibliography of the references found in this guideline can be
found in Appendix H.
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For Management of Substance Use Disorders
Implementation
The guideline and algorithms are designed to be adapted to individual facility needs and resources.
The algorithms will serve as a guide that providers can use to determine best interventions and timing
of care for their patients to optimize quality of care and clinical outcomes. This should not prevent
providers from using their own clinical expertise in the care of an individual patient. Guideline
recommendations are intended to support clinical decision-making but should never replace sound
clinical judgment.
Although this guideline represents the state-of-the-art practice at the time of its publication, medical
practice is evolving and this evolution will require continuous updating of published information. New
technology and more research will improve patient care in the future. The clinical practice guideline
can assist in identifying priority areas for research and optimal allocation of resources. Future studies
examining the results of clinical practice guidelines such as these may lead to the development of new
practice-based evidence.
Outcomes
1. Reduction of consumption
2. Improvement in quality of life (social and occupational functioning)
3. Improvement of symptoms
4. Improvement of retention (keeping patients engaged in the program)
5. Improvement in co-occurring conditions
6. Reduction of mortality.
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VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
VA DoD
FACILITATOR
Oded Susskind, MPH
RESEARCH TEAM – ECRI HEALTHCARE QUALITY INFORMATICS, INC.
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VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
DEFINITIONS
DIAGNOSED SUBSTANCE USE DISORDERS (DSM IV, American Psychiatric Association, 1994)
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4. There is a persistent desire or there are unsuccessful efforts to cut down or control substance use.
5. A great deal of time is spent in activities necessary to obtain the substance (e.g., visiting multiple
doctors or driving long distances to see one), use the substance (e.g., chain smoking), or recover
from its effects.
6. Important social, occupational, or recreational activities are given up or reduced because of
substance use.
7. The substance use is continued despite knowledge of having a persistent or recurrent physical or
psychological problem that is likely to have been caused or exacerbated by the substance (e.g.,
current cocaine use despite recognition of cocaine-induced depression or continued drinking despite
recognition that an ulcer was made worse by alcohol consumption).
Dependence exists on a continuum of severity: remission requires a period of at least 30 days
without meeting full diagnostic criteria and is specified as Early (first 12 months) or Sustained
(beyond 12 months) and Partial (some continued criteria met) versus Full (no criteria met).”
SETTINGS OF CARE
General healthcare settings can be broadly defined as outpatient clinic settings including primary
care, psychiatry, or other specialty clinics (e.g., HIV, hepatology clinics, medical, pre-operative) and
may include emergency departments and surgical care clinics.
Specialty SUD Care focuses on patients in need of further assessment or motivational enhancement or
who endorse rehabilitation goals.
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For Management of Substance Use Disorders
MODULE A: SCREENING AND INITIAL ASSESSMENT FOR SUBSTANCE USE 11
A. All Patients Seen in VA or DoD General Medical and Mental Healthcare Settings 11
B. Screen Annually for Unhealthy Alcohol Use Using Validated Tool 11
C. Does the Person Screen Positive or Drink Despite Contraindications? 14
D. Assess Current Alcohol Consumption 15
E. Does the Person Drink Above Recommended Limits or Despite Contraindications? 16
F. Provide Brief Intervention 17
G. Is Referral for Alcohol Use Disorder Also Indicated or Requested?/Offer Referral, if Appropriate 19
H. Does Patient Agree to the Referral or is the Referral Mandated? 20
I. Continue to Provide Brief Interventions During Future Visits 20
J. Provide Positive Feedback Regarding Changes 22
K. Advise to Stay Below Recommended Limits 22
L. Screen Annually for Unhealthy Alcohol Use 23
MODULE B: MANAGEMENT OF SUD IN SPECIALTY SUD CARE 25
A. Patient with Presumptive or Possible Substance Use Disorder (SUD) Referred or
Self-Referred to Specialty Care 25
B. Ensure Behavioral or Physiological Stabilization, if Necessary 25
C. Obtain a Comprehensive Biopsychosocial Assessment 25
D. Determine Diagnosis of SUD; Develop Integrated Summary and Initial Treatment Plan 27
E. Initiate Addiction-Focused Pharmacotherapy (If Indicated) 31
F. Initiate Addiction-Focused Psychosocial Interventions 31
G. Address Psychosocial Functioning and Recovery Environment 32
H. Manage General Medical and Psychiatric Co-occurring Conditions 33
I. Assess Response to Treatment / Monitor Biological Indicators 34
J. Reinforce and Follow Up 34
K. Are Treatment Goals Achieved? 35
L. Discontinue Specialty SUD Treatment; Develop Aftercare/Recovery Plan 35
M. Reevaluate Treatment Plan Regarding Setting and Strategies 37
MODULE C: MANAGEMENT OF SUD IN (PRIMARY) GENERAL HEALTHCARE 40
A. Patient with Presumptive or Possible Substance Use 40
B. Ensure Behavioral or Physiological Stabilization, if Necessary 40
C. Complete Assessment and Diagnostic Evaluation 41
D. Assess Co-Occurring Conditions (Psychiatric Illness, Medical Conditions,
Legal or Psychosocial Conditions) 42
E. Summarize the Patient's Problem(s), Discuss Treatment Options, and Arrive at
Shared Decision Regarding the Treatment Plan 43
F. Referral to Specialty SUD Care 45
MODULE P: ADDICTION‐FOCUSED PHARMACOTHERAPY 55
A. Patient with Substance Use Disorder (SUD) 55
B. Does the Patient Meet DSM-IV Criteria for Opioid Dependence? 55
PHARMACOTHERAPY FOR OPIOID DEPENDENCE ................................................................................................. 55
C. Is Opioid Agonist Treatment (OAT) Medication Appropriate for, and Acceptable to, the Patient? 55
D. Is Treatment in a Specialized Opioid Agonist Treatment Program (OATP)
Setting Appropriate for the Patient? 58
E. Initiate Opioid Agonist Treatment in an Opioid Agonist Treatment Program (OATP)
or Office-Based Opioid Treatment (OBOT) 61
F. Is Naltrexone Appropriate for and Acceptable to the Patient? 63
G. Assure Patient is Withdrawn from Opioids and Opioid Free Before Continuing 65
H. Initiate Naltrexone for Opioid Dependence with Patient Education and Monitoring 66
PHARMACOTHERAPY FOR ALCOHOL DEPENDENCE ............................................................................................. 67
I. Is the Patient Alcohol Dependent? 67
J. Initiate Pharmacotherapy for Alcohol Dependence? 67
MODULE S: STABILIZATION and WITHDRAWAL MANAGEMENT 75
A. Substance-Using Patient Who May Require Physiological Stabilization 75
B. Obtain History, Physical Examination, Mental Status Examination (MSE),
Medication Including Over-The-Counter (OTC), and Lab Tests as Indicated 75
C. Is the Patient in Any Immediate Medical or Psychiatric Crisis or Intoxicated? 75
D. Provide Appropriate Care To Stabilize; or, Follow Policies For DoD Active Duty Members: Keep
Commanding Officer Informed 77
E. Assess Level of Physiological Dependence and Indications for Stabilization Including Risk of
Withdrawal 78
F. Is the Patient in Need of Withdrawal Management? 79
G. Does Patient Require Inpatient Medically Supervised Withdrawal? 81
H. Admit to Inpatient Withdrawal Management or Initiate Ambulatory Withdrawal Management 82
I. Was Withdrawal Management Successful? 89
J. Is Care Management Indicated? 89
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A. All Patients Seen in VA or DoD General Medical and Mental Healthcare Settings
All patients seen in primary care settings are the target population for alcohol screening.
BACKGROUND
DISCUSSION
Based on rigorous evaluation of clinically preventable burden, the U.S. Prevention Priorities
Commission concluded that of the practices recommended by the USPSTF (2008), Unhealthy Alcohol
Use screening and counseling is similar to screening for hypertension, colorectal cancer, or vision in
older adults, and a higher priority than breast and cervical cancer screening, as well as cholesterol
screening. Clinically preventable burden was based on both the cost-effectiveness of alcohol screening
and counseling, as well as the alcohol-attributable fraction of morbidity and mortality (Maciosek et al.,
2006; Solberg et al., 2008).
BACKGROUND
Screening should identify patients along the entire continuum of Unhealthy Alcohol Use including
those who drink above recommended limits (often called risky or hazardous drinking) to those with
severe alcohol dependence. Most screen-positive patients will not be in treatment for alcohol use
disorders and the initial approach to Unhealthy Alcohol Use will include brief alcohol counseling
(often termed “brief interventions”) or referral.
RECOMMENDATIONS
1. Patients in general and mental healthcare settings should be screened for Unhealthy Alcohol Use
annually. [A]
2. Use a validated screening questionnaire for past-year Unhealthy Alcohol Use. [A]
3. Select one of two brief methods of screening: [A]
a. The Alcohol Use Disorders Identification Test Consumption Questions (AUDIT-C) or
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For Management of Substance Use Disorders
b. Ask whether patient drank any alcohol in the past year and administer the Single-Item
Alcohol Screening Questionnaire (SASQ) to assess the frequency of heavy drinking in
patients who report any drinking. (see Annotation C)
4. The CAGE questionnaire alone is not a recommended screen for past-year Unhealthy Alcohol Use
(e.g., risky or hazardous drinking). [D]
5. The CAGE questionnaire, used as a self-assessment tool, may be used in addition to an
appropriate screening method to increase patinet’s awareness to unhealthy use or abuse of alcohol.
See Appendix B for examples of the Screening Instruments
DISCUSSION
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Other Commonly Recommended Screening Tests (CAGE augmented with 2-3 additional questions
and 10-item AUDIT)
Several longer screening questionnaires are generally as effective but less practical for population-
based screening. They include augmented 7 to 8-item versions of the CAGE and the WHO 10-item
AUDIT (Bradley et al., 2007; Bradley et al., 1998; Fleming & Barry, 1991; Seale et al., 2006;
Steinbauer et al., 1998; Volk et al., 1997). If the 10-item AUDIT is used, the appropriate screening
cut-points for Unhealthy Alcohol Use are 4 or more (women) or 5 or more (men) to balance sensitivity
and specificity in U.S. outpatients (including VA outpatients) (Bradley et al., 2007; Steinbauer et al.,
1998; Volk et al., 1997), not 8 or more as is sometimes misreported (Fiellin et al., 2000; Reinert &
Allen, 2002).
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Screening for Unhealthy Alcohol Use Maciosek et al., 2006 I Good A
should be offered to all VA/DoD general Solberg et al., 2008
and mental health care patients routinely USPSTF, 2004
2 Screening for Unhealthy Alcohol Use Working Group Consensus III Poor I
should be offered annually
3 The AUDIT-C is a valid and reliable Bradley et al., 2003; 2007 I Good A
screening instrument for identifying the Bush et al., 1998
spectrum of Unhealthy Alcohol Use in Dawson et al., 2005
U.S. outpatients Frank et al., 2008
Gordon et al., 2001
4 Single-item alcohol screening Bush et al., 1998 I Good A
questionnaires (SASQ) regarding heavy Seale et al., 2006
episodic drinking are valid and reliable Williams & Vinson, 2001
instruments for identifying the spectrum of NIAAA, 2007
Unhealthy Alcohol Use in US outpatients
5 There is insufficient evidence to support AHRQ, 2008 III Poor I
screening for drug use/abuse in unselectedMcPherson & Hersch, 2000
primary care populations USPSTF, 2008
Yudko et al., 2007
6 The CAGE is not recommended alone for Bradley et al., 2001 I Good D
screening for risky drinking as well as Fleming & Barry, 1991
alcohol use disorders Wallace & Haines, 1985
7 The WHO full AUDIT is also valid and Bradley et al., 1998 I Good A
reliable for identifying the spectrum of Bradley et al., 2007
Unhealthy Alcohol Use in US outpatients, Steinbauer et al., 1998
but is 10 items long Volk et al., 1997
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
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BACKGROUND
Screening is intended to identify patients with Unhealthy Alcohol Use but also patients who are
drinking despite contraindications to alcohol use even if they screen negative for Unhealthy Alcohol
Use.
RECOMMENDATIONS
1. Consider a screen positive for Unhealthy Alcohol Use if: [B]
a. AUDIT-C score (range from 0 to 12) is > 4 points for men or > 3 points for women
b. Patients report drinking 4 or more (women) or 5 or more (men) drinks in a day in the past
year on the single-item screening question.
2. Identify contraindications for any alcohol use [C]. Contraindications to alcohol use include:
a. Pregnancy or trying to conceive
b. Liver disease including hepatitis C
c. Other medical conditions potentially exacerbated or complicated by drinking (e.g.,
pancreatitis, congestive heart failure)
d. Use of medications with clinically important interactions with alcohol or intoxication
(e.g., warfarin)
e. An alcohol use disorder.
DISCUSSION
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• Lower screening cut-points in women: This reflects the fact that women develop problems
due to drinking at lower levels (Bradley et al., 1998); therefore lower levels of alcohol use are
defined as risky drinking in women.
• The role of prevalence: When the prevalence of Unhealthy Alcohol Use is low (e.g., in
women in certain settings) a slightly higher screening threshold will often be optimal to avoid
excess false positive tests. Therefore, although a screening threshold of > 2 for the AUDIT-C
also balances sensitivity and specificity in women (Bradley et al., 2007; Bradley et al., 2003);
the higher cut-point (> 3) is typically used.
• The cost of false positives: The exact cut-point used for any particular setting differs
depending on the costs of a false positive compared to the benefits of a true positive screening
test (Cantor et al., 1999). For example, in FY 2008, the VA Office of Quality and
Performance used the recommended cut-points for a positive AUDIT-C screening test, but
only required documented follow-up brief alcohol counseling in patients screening positive at
cut-points of 5 or more. This choice was made to simplify implementation (no gender-specific
cutoff), target brief alcohol counseling to patients most likely to benefit and decrease provider
concerns about effort devoted to false positive screens (Bradley et al., 2007; Bradley et al.,
2003).
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 In primary care settings AUDIT- Bradley et al., 2003 II-2 Good B
C scores of > 4 for men and > 3 Bradley et al., 2007
for women should be considered Dawson et al., 2005
positive. Frank et al., 2008
2 Use of a higher AUDIT-C cut- Bradley et al., 2003 II-2 Good B
point may be supported in some Bradley et al., 2007
clinical environments. Dawson et al., 2005
Frank et al., 2008
3 In primary care settings, the NIAAA, 2007 II-2 Good B
optimal definition of a positive
screen for Unhealthy Alcohol
Use on the SASQ is: drinking 4
or more drinks on an occasion for
women or 5 or more drinks on an
occasion for men in the past year.
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
BACKGROUND
If a patient does not have contraindications to any drinking, experts recommend that alcohol
consumption be evaluated as the first step in a brief intervention. Most, if not all, clinical trials of brief
alcohol counseling have assessed patients’ drinking after screening and only included those who
reported drinking above recommended limits on reassessment.
Epidemiologic studies have shown that drinking above weekly or daily limits is associated with
development of alcohol-related problems.
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RECOMMENDATIONS
1. Determine the number of drinks consumed by the patient in a typical week and the maximum
number of drinks on an occasion in the past month.
DISCUSSION
Patients under-report their typical drinking on screening questions (Bradley et al., 1998; Canagasaby &
Vinson, 2005; Kerr et al., 2003; Kerr & Ye, 2007). Among men who reported drinking above 14
drinks a week according to structured interview, only 54 percent have reported doing so on AUDIT-C
questions 1 and 2 (Bradley et al., 1998).
One approach is to ask the patient how often, what beverages, and when he/she drinks and then follow
with specific questions on how often he/she drinks 5 or more drinks on an occasion for men or 4 or
more for women. This approach will allow the provider to review the drinking throughout the day, the
drink/bottle sizes, and the number of standard-sized drinks the patient consumes. Another is to review
drinking for each of the previous 7 days (retrospective drinking diary). Either way, the goal is to
assess whether the patient drinks above recommended limits.
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Patients who screen positive for Working Group Consensus III Poor I
Unhealthy Alcohol Use should be
assessed regarding current alcohol
consumption to identify if they drink
above recommended limits prior to
brief intervention
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
BACKGROUND
Patients who drink above the recommended limits or those who have clinical conditions that
contraindicate alcohol use are candidates for a brief intervention.
RECOMMENDATIONS
1. Determine whether patient drinks above recommended limits. [A]
a. The recommended limits are:
- FOR MEN— no more than 14 standard-sized drinks a week and no more than 4 standard-
sized drinks on any day
- FOR WOMEN— no more than 7 standard-sized drinks a week and no more than 3
standard-sized drinks on any day
Standard-sized drinks are: 12 oz beer, 5 oz wine, or 1.5 oz hard liquor.
2. Contraindications for any alcohol use include:
a. Pregnancy or trying to conceive
b. Liver disease including hepatitis C
c. Other medical conditions potentially exacerbated or complicated by drinking (e.g.,
pancreatitis, congestive heart failure)
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BACKGROUND
A brief intervention typically lasts from several minutes up to an entire visit and is a patient-centered,
empathetic brief counseling intervention that can be offered by a clinician who is not a specialist
addictions provider or counselor.
A brief intervention for Unhealthy Alcohol Use is a single session or multiple sessions that include
motivational discussion focused on increasing insight and awareness regarding alcohol use and
motivation toward behavioral change. Brief interventions can be tailored for variance in population or
setting and can be used as a stand-alone treatment for those at-risk as well as a vehicle for engaging
those in need of more extensive levels of care.
RECOMMENDATIONS
1. Provide a brief intervention (counseling) for alcohol use, which includes the following
components: [A]
a. Express concern that the patient is drinking at unhealthy levels known to increase his/her
risk of alcohol-related health problems
b. Provide feedback linking alcohol use and health, including:
- Personalized feedback (i.e., explaining how alcohol use can interact with
patient’s medical concerns [hypertension, depression/anxiety, insomnia, injury,
congestive heart failure (CHF), diabetes mellitus (DM), breast cancer risk,
interactions with medications]) OR
- General feedback on health risks associated with drinking.
c. Advise:
- To abstain (if there are contraindications to drinking) OR
- To drink below recommended limits (specified for patient).
d. Support the patient in choosing a drinking goal, if he/she is ready to make a change
e. Offer referral to specialty addictions treatment if appropriate.
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DISCUSSION
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G. Is Referral for Alcohol Use Disorder Also Indicated or Requested?/Offer Referral, if Appropriate
BACKGROUND
Scores of controlled studies over several decades consistently show that a variety of forms of alcohol
dependence treatment including behavioral interventions and pharmacotherapies significantly reduce
alcohol consumption among alcohol-dependent patients.
Specialty addictions programs or mental health providers integrated in primary care settings who have
addictions expertise can be helpful for assessment, motivational interviewing and treatment. Patients
who are open to assessment or who are ready for assistance should be referred to a specialty addictions
provider or program, or mental health provider integrated in primary care.
RECOMMENDATIONS
1. Offer referral to specialty SUD care for addiction treatment if the patient:
a. May benefit from additional evaluation of his/her drinking or substance use and related
problems or from motivational interviewing
b. Has tried and been unable to change drinking or substance use on his/her own or does not
respond to brief intervention
c. Has been diagnosed for alcohol or other substance dependence
d. Has previously been treated for an alcohol or other substance use disorders
e. Has an AUDIT-C score > 8.
2. DoD active duty members involved in an incident in which substance use is suspected to be a
contributing factor are required to be referred to specialty SUD care for evaluation. Command
should be contacted to discuss administrative and clinical options if the member refuses to be
evaluated (see Appendix D).
DISCUSSION
Experts recommend that certain groups of patients be offered referral to specialty addictions treatment
at the time of the initial brief intervention. The efficacy of referral to specialty addictions care by a
primary care provider has not been extensively evaluated but is indicated because many brief
intervention trials have excluded patients with the most severe problem drinking, and instead referred
such patients to specialty treatment. Brief intervention should nevertheless be offered to patients who
are referred, because many will not follow through with the referral.
A meta-analysis of 7 multi-site controlled trials (total of 8,389 patients with alcohol dependence) that
examined the efficacy of either medications or behavioral interventions indicated that 24 percent of
patients maintained total abstinence for 12 months. Addiotnally, among the patients not totally
abstinent the percent days abstinent increased 128 percent while standard drinks per drinking day
decreased by 57 percent (Miller et al., 2001). When one considers that medical harm from alcohol
consumption shows a strong dose-response effect, these treatment-related reductions in consumption
appear to be highly clinically meaningful.
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Offer referral to specialty addictions Working Group Consensus III Poor I
care if indicated
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
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BACKGROUND
Many patients may initially decline voluntary referral, but provider encouragement and support may
improve patient willingness to complete the referral.
RECOMMENDATIONS
1. Agree on a set of specific goals with the patient.
a. Review with the patient results of previous efforts of self-change and formal treatment
experience, including reasons for treatment dropout
b. Ask patient about willingness to accept referral
c. Consider bringing an addiction specialist into a general medical or mental health visit to
assist with referral decision.
2. Patients at high risk for alcohol use disorder but who are not ready for specialty addictions
treatment should be engaged in monitoring of alcohol-related medical problems in the medical
setting.
3. DoD active duty members involved in an incident in which substance use is suspected to be a
contributing factor are required to be referred to specialty SUD care for evaluation. Command
should be contacted to discuss administrative and clinical options if the member refuses to be
evaluated (see Appendix D).
DISCUSSION
Many patients will not accept referrals (Oslin et al., 2006). However, attempted referral may have
some benefit (Elvy et al., 1988), and patients who recall a physician’s advice prior to alcohol treatment
have better outcomes (Walsh et al., 1992). More patients are successfully referred to alcohol
counselors in primary care settings if nurses refer patients directly instead of relying on primary care
providers to refer (Goldberg et al., 1991). An older study showed that addressing the patient’s needs
and concerns increased the acceptance of referral (Chafetz, 1968).
BACKGROUND
Patients should be frequently re-evaluated to follow progress, assessed for changes in alcohol-related
biomarkers if possible, and supported to problem-solve if barriers to improvement are encountered.
Periodically, the patient’s interest in specialty treatment and mutual support groups should be re-
evaluated. Patient-centered approaches such as motivational interviewing may be helpful.
The interval of follow-up for a particular patient will depend on individual circumstances including
(but not limited to) the severity of their Unhealthy Alcohol Use, the exsitence of co-occurring
conditions, readiness to change, and personal circumstances (difficulty making appointments due to
employment or other responsibilities).
RECOMMENDATIONS
1. Address alcohol at the next medical visit scheduled to address other issues, or schedule a separate
appointment to specifically address drinking if the patient agrees. [B]
2. Repeat brief intervention at the follow-up visit if the patient has not responded to a previous brief
intervention. [B]
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DISCUSSION
There is evidence that most patients will not respond to a single brief intervention and that repeated
brief interventions can be efficacious. Moreover, there are additional interventions that should be
offered to patients who do not respond to brief intervention.
Although there is not consistent evidence of a dose-response relationship for brief interventions (Kaner
et al., 2007), most brief intervention trials, especially those with improvement in outcome measures
other than self-reported drinking, have included follow-up visits (Fleming et al., 1997; Wallace et al.,
1988).
Repeated brief interventions appear to be especially efficacious when they have a medical focus. For
example, monitoring of medications to decrease drinking was efficacious with active medications for
alcohol dependence (Addolorato et al., 2007; Anton et al., 2006; Johnson et al., 2007) as well as
placebo (Anton et al., 2006). In addition, monitoring lab or physiologic measures and feedback to
patients on abnormal laboratory tests associated with Unhealthy Alcohol Use (Fleming et al., 2004;
Kristenson et al., 1983; Willenbring & Olson, 1999) or blood pressure (Maheswaran et al., 1992) is
associated with improved outcomes. One study of VA patients hospitalized for medical problems due
to drinking (who were not willing to enter addictions treatment) showed that such repeated primary
care interventions could result in abstinence even when the intervention did not require that the patient
start with a goal of abstinence (74 percent vs. 48 percent reported 30-day abstinence at 2 years for the
intervention and usual care groups, respectively) (Willenbring & Olson, 1999).
No research comparing different follow-up intervals was identified. No other guideline specifies the
exact timing when patients should be followed up after a brief intervention. Most brief intervention
trials included a “booster” at 1 to 2 and 3 to 4 months. Some studies found that patients who returned
for more sessions had improved outcomes.
Repeated Interventions for Severe Unhealthy Alcohol Use using Labs and Medications
The focus of these medical visits is on clinical engagement without requiring immediate abstinence
and can include monitoring any or all of the following:
• A physiologic biomarker of Unhealthy Alcohol Use, including blood pressure or laboratory
tests (Gamma Glutamyl Transferase (GGT), Mean Corpuscular Volume (MCV), Glycosylated
hemoglobin (HbA1c), Carbohydrate-Deficient Transferrin (CDT))
• Use of medications: naltrexone, acamprosate, or disulfiram (see Module P).
• Other medical symptoms the patient cares about that are related to alcohol use (e.g.,
hypertension, GERD, depression).
A number of studies have shown that repeated interventions focused on the physical complications of
drinking or medication management can be effective even with patients with severe Unhealthy Alcohol
Use. The first of these studies included men in Malmo, Sweden who had abnormal liver function tests
(LFTs). Repeated medical interventions decreased both LFTs and alcohol-related deaths (Kristenson
et al., 1983; Kristenson et al., 2002).
A study of patients with diabetes and/or hypertension showed that using percent carbohydrate deficient
transferrin (%CDT) as a biomarker to provide monthly feedback on excessive drinking significantly
decreased drinking and %CDT at 12-month follow-up (Fleming et al., 2004). A study of patients
willing to enter a trial for a medication to improve alcoholic liver disease, showed that nurse
monitoring was associated with marked decrease in drinking from an average of 16 to an average of
2.5 drinks daily (Lieber et al., 2003). A study of medications for alcohol dependence found that
medical monitoring and placebo were as effective as acamprosate or a combined behavioral
intervention among patients with alcohol dependence recruited to a trial of medications to help
decrease drinking (Anton et al., 2006).
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For Management of Substance Use Disorders
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Patients who do not respond Ballesteros et al., 2004 II-2 Fair B
after first brief intervention Bertholet et al., 2005
should have a repeat brief Bien et al., 1993
intervention Kahan et al., 1995
Kaner et al., 2007
Moyer et al., 2002
Poikolainen, 1999
Solberg et al., 2008
Wilk et al., 1997
2 Monthly monitoring decreases Fleming et al., 2004 II-1 Fair B
drinking in alcohol-dependent Kristenson et al., 1983
patients or patients with Kristenson & Osterling, 2002
Unhealthy Alcohol Use with Lieber et al., 2003
chronic diseases or Willenbring & Olson, 1999
complications of drinking (e.g.,
elevated GGT)
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
BACKGROUND
Expert opinion supports optimistic, empathetic interventions that note the importance of the changes
patients have made to their health, provide positive feedback and encourage continued drinking below
recommended limits.
RECOMMENDATIONS
1. Provide positive feedback to patients for decreases in drinking.
2. Relate changes in drinking to any changes in presenting health conditions.
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Provide positive feedback Working Group Consensus III Poor I
regarding changes patient
makes in drinking
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
BACKGROUND
Patients who screen positive near the screening threshold of the AUDIT-C (3-5) can report drinking
within recommended limits, but many are under-reporting drinking. Therefore, based on Working
Group consensus, patients who initially screen positive for Unhealthy Alcohol Use but report drinking
below recommended limits should nevertheless be explicitly advised about recommended limits and
encouraged to continue drinking below those limits.
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For Management of Substance Use Disorders
RECOMMENDATIONS
1. Advise patients who screen positive for Unhealthy Alcohol Use but who report drinking below
recommended limits to continue to drink below recommended limits.
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Advise patients who report Working Group Consensus III Poor I
drinking below recommended
limits to avoid drinking above
recommended limits.
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
BACKGROUND
No trials have compared different intervals of screening. This recommendation for annual screening is
based on Working Group consensus consistent with routine annual preventive screening for other
disorders in VA/DoD primary care setting and the past-year assessment window of the AUDIT-C.
RECOMMENDATIONS
1. Repeat alcohol screening annually.
Module A - Page 23
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For Management of Substance Use Disorders
Module B -Page24
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
A. Patient with Presumptive or Possible Substance Use Disorder (SUD) Referred or Self-Referred to
Specialty Care
BACKGROUND
Patients may be referred to this module based on the following indications for treatment: hazardous
substance use, substance abuse, substance dependence, risk of relapse, suspected or possible SUD, or
mandated referral within the DoD. Patients seeking to achieve remission may be appropriately
managed using this module. Other patients may be ambivalent about rehabilitation goals and may
benefit from more comprehensive assessment and discussion of treatment options. Finally, patients
may be referred to a specialist for more extensive evaluation of risks related to substance use.
BACKGROUND
Most patients referred to specialty SUD care are not acutely intoxicated or in need of immediate
physiological stabilization prior to initiating assessment and treatment planning. Others may have
been stable at the time of referral, but require stabilization when they present for specialty SUD care
evaluation or treatment and should be managed using Module S: Stabilization and Withdrawal
Management.
RECOMMENDATIONS
1. Assure patient safety and readiness to cooperate with further assessment by referring the patient to
an emergency department or appropriate setting for stabilization as needed.
BACKGROUND
Comprehensive and multidimensional assessment procedures are needed to evaluate an individual’s
strengths, needs, abilities, and preferences, and to determine priorities so that an initial treatment plan
can be developed. In less severe cases, the assessment should at least involve screening of these
elements, through the use of a multidimensional screening instrument.
RECOMMENDATIONS
1. Obtain a comprehensive biopsychosocial assessment that includes all of the following: *
a. History of the present episode, including precipitating factors, current symptoms and
pertinent present risks:
• Family history:
- Family alcohol and drug use history, including past treatment episodes
- Family social history, including profiles of parents (or guardians or other
caretakers), home atmosphere, economic status, religious affiliation,
cultural influences, leisure activities, monitoring and supervision, and
relocations
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DISCUSSION
Assessment is the beginning of the therapeutic process. A comprehensive biopsychosocial assessment
covers physical, emotional, cognitive, behavioral, emotional, and environmental domains.
The guidelines do not exclusively endorse the use of any particular instrument as the basis for a
comprehensive assessment. However, the Addiction Severity Index (ASI) (Fureman et al., 1990;
McLellan et al., 1992) is a standardized, rater-administered interview that assesses seven functional
domains considered important in an overall addiction evaluation: medical status, employment status,
legal problems, family/social relations, drug use, alcohol use, and psychiatric status. Formal DSM-IV-
TR psychiatric diagnoses are derived from the clinical interview.
Ensuring appropriate housing and access to care is an important part of the assessment process. The
term "housing" is used generically as the residence of a patient while receiving treatment. It can
involve the same setting within which treatment takes place or it can refer to a variety of living
situations with varying degrees of supervision that are separate from the location of treatment services
(see Appendix B-10).
For military service members, access to care and housing may be dependent on the echelons of
military medical care, particularly in a deployed environment. For example, a soldier requiring
substance abuse treatment may need to be evacuated to higher levels of care from Level 1 (Battalion
Aid Station) to Level II (Forward Surgical Team) to Level III (Combat Support Hospital) to Level IV
(Definitive Care).
The clinician's empathic and non-judgmental interest during assessment can help the patient make
sense of his or her condition, decrease the patient’s sense of isolation, increase the likelihood of
treatment adherence, and foster growth of the therapeutic alliance. Conclusions from the assessment
should be shared with the patient. The clinician's attitude and manner are important components of the
assessment process. A nonjudgmental, respectful attitude that reflects genuine interest and empathy
will facilitate rapport. Reliability and validity of the assessment will be affected by the degree of trust
in the interviewer and by consideration of the degree to which the patient presents voluntarily or feels
coerced. In determining reliability and validity of the assessment the clinician should also recognize
that recent substance use might affect the patient's presentation during the interview. Memory and
cognitive deficits and impairment of judgment and mood, secondary to drug use, may be present. The
clinician should monitor the patient's cognitive function and mental status during the assessment. If it
is possible to gain permission from the patient to do so, consulting with collateral informants (e.g.,
spouse/partner, family, friends, co-workers, and/or chain of command) will provide a useful adjunct to
gathering information directly from the patient.
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Conduct comprehensive Working Group Consensus III Poor I
biopsychosocial assessment
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
D. Determine Diagnosis of SUD; Develop Integrated Summary and Initial Treatment Plan
BACKGROUND
The comprehensive intake assessment report should include a diagnostic formulation, summary of past
treatment response, and integrated summary of all clinically relevant information. Treatment
recommendations should incorporate an interdisciplinary perspective. The patient’s motivational level
and personal goals should be assessed, and this information taken into consideration in selecting
treatment goals and options.
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For Management of Substance Use Disorders
RECOMMENDATIONS
1. Provide a narrative to consolidate and interpret the information obtained during the assessment
process.
2. Include a diagnostic formulation.
3. Include past treatment response and patient’s perspective on current problems.
4. Review the patient’s motivational level, treatment preferences and goals, and consider these
factors, along with an interdisciplinary perspective and available programming, in recommending
specific treatment options. [B]
5. Present and discuss the treatment options with the patient and significant others.
6. Determine whether the treatment plan can be implemented in general health care (including
primary care) based on availability of a willing provider, severity and chronicity of the SUD,
active involvement with recovery supports in the community, prior treatment response, and patient
preference and likelihood of adherence.
7. If treatment in specialty SUD care is appropriate, determine the appropriate initial intensity and
level of specialty SUD care, based on ASAM patient placement criteria. [B]
8. If treatment in specialty SUD care is recommended, determine if it is an acceptable mode of
treatment to the patient.
9. Involve the patient in prioritizing problems to be addressed in the initial treatment plan, and in
selecting specific treatment goals, regardless of the level of care selected (see Table B-1).
10. If the patient does not agree to the treatment plan, provide motivational intervention and offer to
renegotiate the treatment plan.
For DoD Active Duty Members
11. A treatment team shall convene with the patient and command to review the treatment plan and
goals.
Patient seeking help but not - Short- to intermediate-term resolution or partial improvement of
committed to abstinence SUDs for a specified period of time
- Resolution or improvement of at least some coexisting problems
and health-related quality of life
Patient not willing to engage - Engagement in general health treatment process, which may
in treatment and not yet continue for long periods of time or indefinitely
ready to abstain - Continuity of care
- Continuous enhancement of motivation to change
- Availability of crisis intervention
- Improvement in SUDs, even if temporary or partial
- Improvement in coexisting medical, psychiatric, and social
conditions
- Improvement in quality of life
- Reduction in the need for high-intensity health care services
- Maintenance of progress
- Reduction in the rate of illness progression
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DISCUSSION
Module B - Page 29
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
DoD active duty members who fail to engage in recommended treatment should be informed that such
a decision could result in involuntary separation from military service.
EVIDENCE TABLE
Module B - Page 30
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
BACKGROUND
Addiction-focused pharmacotherapy should be considered, available and offered if indicated, for all
patients with opioid dependence and/or alcohol dependence. Addiction-focused pharmacotherapy
should be provided in addition to indicated pharmacotherapy for co-occurrring psychiatric conditions.
In addition, it should be directly coordinated with specialty psychosocial treatment and adjunctive
services for psychosocial problems as well as with the patient’s primary care and/or general mental
health providers.
RECOMMENDATIONS
1. Discuss addiction-focused pharmacotherapy options with all patients with opioid and/or alcohol
dependence.
2. Initiate addiction-focused pharmacotherapy if indicated and monitor adherence and treatment
response.
(See Module P for specific recommendations and evidence.)
BACKGROUND
The goals of evidence-based psychosocial treatment for SUD are to engage the patient to establish
early problem resolution or remission, improve psychosocial functioning and prevent relapse to
substance use. A number of effective psychosocial interventions have been developed and evaluated,
and there is no clear evidence that any one of these approaches is the treatment of choice or can be
accurately matched to specific patient characteristics. There is considerable evidence from
psychotherapy research that general factors such as therapist skill, the strength of the therapeutic
alliance, and the structure provided by regular treatment contact can have as powerful an effect as the
specific content or conceptual approach of the interventions. Therefore, attention to these general
therapeutic factors is at least as important as the specific treatment approach selected.
RECOMMENDATIONS
1. Indicate to the patient and significant others that treatment is more effective than no treatment (i.e.,
“Treatment works”).
2. Consider the patient’s prior treatment experience and respect patient preference for the initial
psychosocial intervention approach, since no single intervention approach has emerged as the
treatment of choice.
3. Regardless of the particular psychosocial intervention chosen, use motivational interviewing style
during therapeutic encounters with patients and emphasize the common elements of effective
interventions including: enhancing patient motivation to stop or reduce substance use, improving
self-efficacy for change, promoting a therapeutic relationship, strengthening coping skills,
changing reinforcement contingencies for recovery, and enhancing social support for recovery.
4. Emphasize that the most consistent predictors of successful outcome are retention in formal
treatment and/or active involvement with community support for recovery.
5. Use strategies demonstrated to be efficacious to promote active involvement in available mutual
help programs (e.g., Alcoholics Anonymous, Narcotics Anonymous).
Module B - Page 31
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For Management of Substance Use Disorders
BACKGROUND
Many patients have co-existing psychosocial problems that affect their likelihood of establishing and
maintaining good clinical outcome and improved functional status.
Some of these problems are consequences of SUD that persist even after early recovery is established.
Others occur independently of SUD, but can complicate access to care or present relapse risk. These
problems include access to a supportive recovery environment (housing and social support for
sobriety), difficulties with family and social relationships, unemployment/underemployment, and/or
unresolved legal issues.
RECOMMENDATIONS
1. Prioritize and address other coexisting biopsychosocial problems with services targeted to these
problem areas, rather than increasing intensity of addiction-focused psychosocial treatment alone.
[B]
2. Address transitional housing needs to facilitate access to treatment and promote a supportive
recovery environment.
3. Provide social/vocational/legal services in the most accessible setting to promote engagement and
coordination of care.
4. Address deferred problems as part of treatment plan updates and monitor emerging needs.
5. Coordinate care with other social service providers or case managers.
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Identifying and addressing other Friedmann et al., 2004 I Fair B
biopsychosocial problems may be McLellan et al., 1997
more effective than increasing the McLellan et al., 1998
intensity of addiction focused
treatments
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
Module B - Page 32
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
BACKGROUND
In addition to the standard addiction-focused services, programs should address psychiatric and general
medical conditions that exist in association with the SUD. Treatment services directed toward these
additional problems, when they exist, are associated with improvement. Problems typically show little
spontaneous improvement if services are not provided.
RECOMMENDATIONS
1. Prioritize and address other medical and psychiatric co-occurring conditions.
2. Recommend and offer cessation treatment to patients with nicotine dependence.
3. Treat concurrent psychiatric disorders consistent with VA/DoD clinical practice guidelines (e.g.,
Major Depressive Disorder, Bipolar Disorder, Post Traumatic Stress, Psychoses) including
concurrent pharmacotherapy.
4. Provide or arrange treatment via referral for medical conditions (e.g. management of diabetes,
chronic heart failure, management of unexplained medical symptoms). (See other VA/DoD
Clinical Practice Guidelines at: www.healthquality.va.gov)
5. Provide multiple services in the most accessible setting to promote engagement and coordination
of care.
6. Monitor and address deferred problems and emerging needs through ongoing treatment plan
updates.
7. Coordinate care with other providers.
DISCUSSION
Treatment providers should identify psychiatric and medical comorbidities, and evaluate the degree to
which they are associated with the SUD. The ASI and other information from the biopsychosocial
assessment (e.g., urine drug screen, tests for HIV and Hepatitis C and other lab results, physical exam,
mental status exam, and patient report) and integrated summary can be used to make this evaluation.
When problems are identified, and their severity and relationship to the SUD determined, the provider
and treatment team should determine the optimal timing and setting for the interventions. For example,
the need for immediate or delayed referral to a specialized program for a patient with a chronic co-
occurring psychiatric condition.
Nicotine and alcohol interact in the brain, each drug possibly affecting vulnerability to dependence on
the other (Schiffman & Balabanis, 1995). Initial studies suggest that recovery rates from non-nicotine
SUDs are significantly improved in patients who reduce their nicotine usage prior to discharge from
structured rehabilitation settings, versus those nicotine addicts who do not reduce their nicotine use
(Frosch, et al., 2000). Consequently, some researchers postulate that treating both addictions
simultaneously might be an effective, even essential, way to help reduce dependence on both (NIAAA,
2000).
When unavailable through the primary treatment team, patients may need referral to other clinics in
order to access needed services, such as primary medical care or psychiatric evaluation. Providing
these services in a single setting (one-stop service) may be more effective (Umbricht-Schneiter et al.,
1994). Other facilities will need to develop referral resources and feedback mechanisms. Either way,
ongoing communication and coordination among service providers is essential to quality care.
Module B - Page 33
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For Management of Substance Use Disorders
BACKGROUND
At each periodic reassessment, the patient may have achieved the goals set for specialty SUD care, be
successfully completing interim steps toward each goal, not improving, or may have dropped out of
treatment altogether. Periodic monitoring of progress toward treatment goals helps to coordinate care
and to motivate the patient and treatment team members to accomplish interim steps. Periodic
reassessments also provide opportunities to address emerging problems and to change treatment
strategies when the initial plan is not fully successful.
RECOMMENDATIONS
1. Reassess response to treatment periodically and systematically, using standardized and valid self-
report instrument(s) and laboratory tests. Indicators of treatment response include ongoing
substance use, craving, side effects of medication, emerging symptoms, etc. (see example for a
treatment response monitor; Appendix B-9: Brief Addiction Monitor).
DISCUSSION
Reassess and document clinical response throughout the course of treatment:
• Daily in the acute inpatient setting, including reevaluation of the continued need for that level
of care.
• At least weekly in the residential setting, including reevaluation of the continued need for that
level of care.
• In the outpatient setting:
o Weekly during the first few weeks for a new episode of care
o At least monthly thereafter.
BACKGROUND
For many patients, substance use disorders are chronic conditions that warrant extended efforts at
relapse prevention and encouragement by providers for progress.
RECOMMENDATIONS
1. For patients who accomplish their initial goals in early recovery, the treatment team should
collaborate with the patient to develop a continuing care plan (e.g., aftercare plan) which may
include:
a. Transition to an appropriate alternative specialty care setting (see Annotation L -
Aftercare), such as PTSD specialty treatment, etc.
b. Return to primary care.
2. For patients who are progressing toward goals, providers should:
a. Provide positive feedback and encouragement to remain engaged in specialty SUD care
b. Involve patients in identifying the next interim steps toward achieving the goals.
Module B - Page 34
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For Management of Substance Use Disorders
DISCUSSION
Consider reduced treatment intensity or discontinuing some treatment components based on:
• Accomplishment of treatment goals and objectives
• Full, early remission
• Early problem resolution
• Greater involvement in community support
• Improvements in other associated problem areas.
Coordinate follow-up with the patient's primary medical or behavioral health provider during
transitions to less intensive levels of care in order to reinforce progress and improve monitoring of
relapse risks.
BACKGROUND
In general, longer lengths of time in treatment correlate with better outcomes for more severely
dependent patients. However when no further addiction-focused specialty treatment visits are
scheduled, care should be transitioned to their primary medical or behavioral healthcare provider for
relapse monitoring and ongoing management of co-occurring general medical and/or psychiatric
conditions.
RECOMMENDATIONS
1. Use the patient’s progress in attaining recovery goals to individualize treatment continuation and
avoid adopting uniform treatment plans with standardized duration and intensity.
2. Consider patient report of craving and other subjective indications of relapse risk.
3. For patients who achieve sustained remission or problem resolution, provide appropriate
continuity of care and follow-up with providers in the general medical or mental health care
setting (see Module C).
DISCUSSION
Emphasize the increased risk of relapse in early recovery and the importance of follow-up, until the
recovery is well-established and the patient no longer meets diagnostic criteria. Monitoring of the
patient’s response to treatment should inform decisions regarding continuation until recovery support
in the patient's daily life is adequately established.
BACKGROUND
An aftercare or recovery plan is a mutual effort between the patient and treatment team to identify and
promote those aspects of continuing care for SUDs that are associated with success in recovery. At the
point that the patient has achieved the initial stabilization goals of intensive treatment, he/she receives
a written plan for continuing care to maintain recovery.
Module B - Page 35
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
RECOMMENDATIONS
1. Provide continuing care following intensive outpatient or residential rehabilitation (individual,
group or telephone follow-up).
2. Consider objective monitoring of substance use and medical consequences. [A]
3. Encourage active involvement in community support for recovery (e.g., Alcoholics Anonymous,
Cocaine Anonymous). [A]
4. As part of the discharge instructions from the intensive phase, provide the patient a written plan to
facilitate compliance with aftercare which may include “the basic things I need to do to meet my
treatment goals,” such as:
a. Information on treatment appointments and prescribed medications
b. Recognizing relapse warning signs and triggers and appropriate coping responses
c. Maintaining contact with recovery support network and identifying mutual help meetings
to attend.
5. For DoD Active Duty: Rehabilitation and Referral Services for Alcohol and Drug Abusers,
requires an individualized aftercare plan designed to identify the continued support of the patient
with monthly monitoring (minimally) during the first year after inpatient treatment.
DISCUSSION
There is good evidence that aftercare (continuing care) following intensive addiction rehabilitation is
associated with improved outcomes for substance use and psychosocial functioning. Common
elements of aftercare include periodic contact with an addiction treatment professional (case
management, group, individual or phone contact), active involvement in 12-step mutual help programs,
and ongoing monitoring of indicators of substance use and/or its medical consequences (urine drug
screens, liver function tests, etc.).
Although there is no direct evidence that a written recovery plan improves outcome, this
recommendation is based in part on regulatory requirements and in part on evidence from compliance
with other medical and mental health treatment that clear written instructions and specific appointment
times improve rates of follow-up.
Recovery Plans can be personalized to the individual patient's needs or the treatment team's discretion.
However, some basic areas to be considered include the following descriptive (rather than prescriptive)
list:
• A listing of the names, dates, and times of mutual support meetings and recovery activities.
For example: 12 Step (or non-12 Step) support meetings the patient will be attending after
rehabilitation (including the frequency of attendance) and first name and phone number of
sponsor(s)
• Follow-up appointments for aftercare and other medical appointment dates, times and
locations as well as phone numbers/addresses (and provider's names, if known).
• A summary of the primary issues the patient has been working on during rehabilitation
treatment and the specific methods the patient intends to use towards resolution of these
issues
• The patient's personally identified relapse warning signs and triggers (with the help of their
sponsor, rehabilitation counselor, etc.), and the respective countering coping skills planned
(Gorski & Miller, 1986)
• A listing of individuals within the patient's identified recovery support network (Galanter,
1997) (other than sponsors and providers) along with some description regarding the role of
each in the patient's recovery.
Module B - Page 36
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
For a DoD individualized aftercare plan, a quarterly evaluation of the patient's progress shall be
conducted by a committee comprised of the patient's commanding officer, his or her representative, the
patient, and an aftercare coordinator or the patient's substance abuse counselor. Following the
completion of outpatient treatment, the aftercare program shall assist the individual in developing a
continuing support plan that will involve the patient's commander. The patient shall have a written
plan describing the military member's further rehabilitative responsibilities with a copy to his or her
commander. The patient's progress shall be evaluated on a quarterly basis during the first year of
recovery by a committee comprised of the patient, an alcohol counselor or aftercare coordinator, and
the patient's commanding officer or representative (DoDI 1010.6, 1985) (see Appendix D).
EVIDENCE TABLE
BACKGROUND
Relapse can be used as a signal to reevaluate the treatment plan rather than evidence that the patient
cannot succeed or that the patient was not sufficiently motivated.
RECOMMENDATIONS
1. For patients who are not improving, providers should consider either:
a. Adding or substituting another medication or psychosocial intervention, or
b. Changing treatment intensity by:
• Increasing the intensity of care, or
• Increasing the dose of the medication, or
• Decreasing the intensity to a minimum level of care that is agreeable to the
patient such as monitoring in general health care (see Module C).
2. If patients drop out of treatment, the treatment team should make efforts to contact the patient and
re-engage him/her in treatment.
Module B - Page 37
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
DISCUSSION
Modify treatment plans based on changes in a patient’s clinical and psychosocial condition rather than
imposing uniform treatment plans (ASAM, 2001). If possible, use treatment algorithms that clearly
specify when to consider a modification to treatment and suggest adaptations to treatment when
progress is less than adequate.
Indications to change treatment intensity or provide adjunctive treatments may include:
• Relapse based on self-report or urine toxicology
• Increased risk of relapse (e.g., craving or personal loss)
• Emergence or exacerbation of co-occurring medical and psychiatric conditions
• Suboptimal response to medication, psychotherapy, or social intervention
• Emergence of medication side effects
• Subsequent substance-related misconduct.
Discuss relapse as a signal to reevaluate the treatment plan rather than evidence that the patient cannot
succeed or was not sufficiently motivated (Miller & Rollnick, 1991).
Target services to identified problems (e.g., psychiatric, medical, family/social, legal, vocational, and
housing) that increase the risk of relapse, rather than increasing drug and alcohol counseling alone
(McLellan et al., 1997).
Consider care management for patients with persistently sub-optimal response, rather than routinely
intensifying rehabilitation or discharging (see Module C).
Module B - Page 38
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Module C - Page 39
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
BACKGROUND
Clinicians in general medical and mental health care settings are likely to encounter patients with
presumptive or possible substance use who are either referred, self-referred, or otherwise seek help
related to substance use. Substance use can include Unhealthy Alcohol Use, misuse of prescription
medications, and illegal substance use (e.g., heroin, cocaine). Substance use conditions are prevalent
among outpatient clinic populations.
General health care settings can be broadly defined as outpatient clinic settings including primary care,
psychiatry, or other specialty clinics (e.g., HIV, hepatology clinics, medical sub-specialty, pre-
operative) and may include emergency departments and surgical care clinics.
All patients in general or in mental healthcare settings should be screened for Unhealthy Alcohol Use.
Population-based screening for other drug use disorder is not recommended. This reflects the lower
prevalence of drug use disorder and the lack of high-quality randomized controlled trials
demonstrating the efficacy of primary care interventions for drug abuse and dependence. Instead,
selective case finding in high-risk populations (e.g., Hepatitis C or HIV clinics), is recommended.
Patients who are diagnosed with SUD or who are seeking help with problem drinking or drug use,
should be offered treatment and/or a referral to specialty addiction treatment, and monitored for
unstable medical or psychiatric conditions. Patients should be referred for acute stabilization or
withdrawal management if needed.
Management of SUD in the general or mental healthcare settings is likely to be a more acceptable and
effective alternative for the patient when one of the following applies:
a. The patient refuses referral to specialty SUD care but continues to seek some services,
especially medical and/or psychiatric services
b. The patient has serious co-morbidity that precludes participation in available specialty
SUD care
c. The patient has been engaged repeatedly in specialty SUD treatment with minimal
progress toward abstinence or sustained improvement.
BACKGROUND
Patients who are intoxicated, undergoing withdrawal, or who are at risk for imminent severe harm
associated with their substance use may be considered medically unstable or at risk for harm of self or
others. These patients may be delirious or otherwise not able to engage collaboratively with a provider
regarding their assessment and treatment. Screening, assessment, or treatment of substance use
disorders should occur in patients who are medically stable.
For example, patients with severe physical dependence on alcohol may undergo alcohol withdrawal
syndrome and may incur hallucinations, seizures, delirium, and delirium tremens. Treatment of
withdrawal symptoms, as well as intoxication with alcohol or opioids, may require specialty treatments
in an inpatient acute care or addiction specialty setting. Patients with cocaine intoxication may require
close cardiac monitoring.
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RECOMMENDATIONS
1. Assure patient safety and readiness to cooperate with further assessment by referring the patient to
an emergency department or appropriate acute care setting for stabilization as needed.
See Module S – Stabilization and Withdrawal Management.
DISCUSSION
An initial evaluation of a patient with SUD should occur to assess medical and psychiatric stability.
Patients with problems that require emergency care or urgent action should not be further managed in
non-addiction specialty settings. Medical conditions (e.g., acute trauma, myocardial infarction, and
stroke) and mental conditions (e.g., delirium, suicidal ideation, or psychosis) may preclude immediate
action on SUD and may not be effectively treated.
BACKGROUND
Comprehensive and multidimensional assessment procedures are needed to evaluate an individual’s
strengths, weaknesses, needs, and preferences and to determine priorities so that an initial treatment
plan can be developed. In less severe cases, the assessment should at least involve screening of these
elements through the use of a multidimensional screening instrument.
A complete evaluation that includes history, physical, and laboratory assessments is important to
properly diagnose patients with SUD. Many patients may be involved with more than one substance
and poly-substance use may not be readily apparent.
For diagnostic criteria of substance abuse and dependence, see Introduction: Definitions (page 6).
RECOMMENDATIONS
1. Patients with suspected, presumed, or identified substance use disorder (SUD) should receive a
comprehensive assessment to include:
a. Medical history, including pertinent medical problems and treatment, surgeries, head
injuries, present medications and allergies and family history of substance use
b. Physical examination including mental status examination (MSE)
c. Laboratory evaluation as indicated.
2. Comprehensive substance use history, including onset and pattern of progression, past sequelae
and past treatment episodes (include all substances, e.g., alcohol, illicit drugs, tobacco, caffeine,
over-the-counter medications, prescription medications, inhalants).
3. Use empathic and non-judgmental (versus confrontational) therapist style, being sensitive to
gender, cultural, and ethnic differences.
4. DoD active duty members involved in an incident in which substance use is suspected to be a
contributing factor are required to be referred to specialty SUD care for evaluation. Command
should be contacted to discuss administrative and clinical options if the member refuses to be
evaluated (see Appendix D).
DISCUSSION
Proper diagnosis of SUD is essential for medical, medico-legal, and fit-to-duty purposes. Every
attempt should be made to formally diagnose patients. This diagnosis aids in management and triage
decisions. Providers should inform the patient that these symptoms or diagnosis are related to SUD.
Baseline laboratory evaluation may also assist in assessing response to treatment. Ongoing
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BACKGROUND
Co-occurring disorders (CODs) are common with SUD and must be identified and addressed as a part
of comprehensive care. CODs, also termed co-morbid disorders, are defined as sub-clinical or
diagnosed medical and/or behavioral health conditions that occur with and influence the SUD
condition. CODs threaten the health of patients and may complicate the treatment of SUD.
SUD is highly correlated with posttraumatic stress disorder and other psychological disorders that may
occur after stressful and traumatic events, such as those associated with war.
RECOMMENDATIONS
1. Identify and document any co-occurring disorders (CODs) in patients with substance use
disorders.
a. Psychiatric history, including symptoms and their relation to substance use, current and
past diagnoses, treatments and providers
b. Infectious diseases (HIV, Hepatitis C, sexually transmitted disease)
c. Nearly all daily nicotine users are nicotine dependent. Identification and treatment of co-
morbid nicotine dependence may improve recovery rates of other SUDs. For patients
using nicotine offer and recommend tobacco use cessation treatment. Use the Clinical
Practice Guideline: Treating Tobacco Use & Dependence: 2008 Update from the U.S.
Department of Health and Human Services at
http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf and the
VA/DoD Clinical Practice Guideline for Management of Tobacco Use
d. Medical COD that may be related to or affected by substance use (e.g., diabetes,
cardiovascular disease, digestive disorders, skin infections, respiratory disorders).
2. Individuals with SUD should be assessed for any significant, unmet psychosocial needs or
situational stressors. These include but are not limited to:
a. Inadequate or no housing
b. Financial difficulties, especially if unable to meet basic needs
c. Problematic family relationships or situations (including caregiver burden or domestic
violence)
d. Poor social support
e. Religious and spiritual problems
f. Occupational problems
g. Difficulties with activities of daily living or instrumental activities of daily living
h. Any other acute or chronic situational stressors.
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DISCUSSION
Most of what is known about the number of cases of CODs was taken from convenience samples.
Those studies in mental health settings found that 20 to 50 percent of patients with lifetime co-
occurring SUD had a lifetime co-occurring mental disorder, while those in SU/SUD treatment settings
found that 50 to 75 percent of patients had such a disorder. One report found that 73 percent of
patients with drug dependence disorder in SUD treatment had a co-occurring mental disorder at some
point during their lifetime.
Of the COD cases reported in substance abuse settings a substantial proportion either had a mental
disorder of low severity or an antisocial personality disorder. In the former instance, SU/SUD
treatment has been found to be effective; in the latter instance, SU/SUD treatment is widely
acknowledged as the treatment of choice. The literature also suggests elevated rates of other forms of
mental disorders, including major depressive disorder and other mood or affective disorders, or
posttraumatic stress disorder, and indicates the diagnosis of more than one mental disorder is not
unusual.
Ongoing data regarding the incidence and prevalence of CODs are obtained from national
epidemiologic studies including the National Comorbidity Survey (NCS, funded by the NIMH), the
National Survey on Drug Use and Health (NSDUH, funded by SAMHSA), and the National
Epidemiologic Study on Alcohol and Related Conditions (NESARC, funded by the NIAAA and
NIDA). (http://ncadi.samhsa.gov/ ; www.coce.samhsa.gov)
Data also suggest that the type and severity of COD depend on the specific substance used or SUD.
High-risk CODs includes a variety of liver (e.g., hepatitis B and C) and cardiac (e.g., cardiomyopathy,
congestive heart failure, arrhythmias, valve disease) disorders. Furthermore, environmental morbidity
such as unemployment, homelessness, family dysfunction and criminality are important and should be
attended to in non-specialty care settings.
An analysis of the Millennium Cohort Study data found that combat deployment in support of the wars
in Iraq and Afghanistan was significantly associated with new-onset heavy weekly drinking, binge
drinking, and other alcohol-related problems among Reserve/Guard and younger personnel after return
from deployment (Jacobson et al., 2008).
Additional information on COD can be found in Treatment Improvement Protocol (TIP) 42, Substance
Abuse Treatment for Persons with Co-Occurring Disorders (Center for Substance Abuse
Treatment [CSAT], 2005.
E. Summarize the Patient's Problem(s), Discuss Treatment Options, and Arrive at Shared Decision
Regarding the Treatment Plan
BACKGROUND
Informed decision-making involves explaining the medical condition, outlining treatment options, and
guiding the patient to a decision about their own care. Even when patients refuse referral or are unable
to participate in specialized addiction treatment, many are accepting of general medical or psychiatric
care.
RECOMMENDATIONS
1. Recognize that feedback about laboratory assessments may improve patients’ motivation to
change and may serve as a baseline to monitor SUD treatment progress.
2. Review the assessment, including diagnosis, past treatment response and the patient’s perspective
on current problems; co-occurring disorders related to SUD; the patient’s motivational level,
treatment preferences and short- and long-term goals.
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3. Present and discuss with the patient appropriate treatment options in a way that motivates ongoing
cooperation with the provider and supports subsequent decisions about referral or brief
intervention.
4. Present and discuss the treatment options with the patient and significant others.
5. Determine which treatments could be offered in general healthcare (including primary care), based
on availability of a provider, severity and chronicity of the SUD, active involvement with recovery
supports in the community, prior treatment response, and patient’s preference and likelihood of
adherence.
6. Involve the patient in prioritizing problems to be addressed in the initial treatment plan, and in
selecting specific treatment goals, regardless of the level of care selected (See Table C – 1).
7. If the patient is not willing to engage in any addictions focused care, provide motivational
intervention and determine whether treatment for medical and psychiatric problems can be
effectively and safely provided. Continue to try to engage the patient in addictions treatment (see
annotation K).
Table C- 1. Treatment Goals and Expected Outcomes
DISCUSSION
Some patients may be able to be managed effectively in non-specialty care, and will not require
referral to specialty care. Factors that are associated with the potential for good outcome in non-
specialty care include the availability of a willing provider with whom the patient has an established
relationship, lower severity and chronicity of the SUD, active involvement with recovery supports in
the community, favorable prior treatment response, and patient’s preference for non-specialty care
rather than specialty care treatment.
For DoD active duty members, a specialty referral is required for patients with presumptive or possible
substance use disorder or following any substance-related incident, and refusal requires contact with
command to discuss administrative and clinical options.
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BACKGROUND
Referral should be offered to patients who are open to assessment or who are ready for assistance from
a specialty addictions provider or program.
RECOMMENDATIONS
1. Offer referral to specialty SUD care for addiction treatment if the patient: [A]
a. May benefit from additional evaluation or motivational interviewing regarding his/her
substance use and related problems
b. Has tried and been unable to change substance use on his/her own or does not respond to
repeated brief intervention
c. Has been diagnosed with substance dependence
d. Has previously been treated for an alcohol or other substance use disorder
e. Has an AUDIT-C score of > 8.
For active duty members, coordinate care with the unit commander.
2. DoD active duty members involved in an incident in which substance use is suspected to be a
contributing factor are required to be referred to specialty SUD care for evaluation. Command
should be contacted to discuss administrative and clinical options if the member refuses to be
evaluated (see Appendix D).
EVIDENCE TABLE
BACKGROUND
Currently, the Food and Drug Administration (FDA) has approved pharmacotherapy for patients
diagnosed with alcohol or opioid dependence. While non-pharmacologic treatment has been the
mainstay of treatment for SUD, recent scientific advances have encouraged the use of pharmacologic
treatments. Pharmacologic treatments can serve as an effective adjunct to non-pharmacologic
treatments to help patients reduce or eliminate alcohol consumption.
RECOMMENDATIONS
1. Discuss pharmacotherapy options with all patients with opioid and/or alcohol dependence.
2. Initiate pharmacotherapy if indicated and monitor adherence and treatment response.
(See Module P for specific recommendations and evidence.)
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DISCUSSION
While non-pharmacologic treatment has been the mainstay of treatment for SUD, recent scientific
advances have encouraged the use of pharmacologic treatments. Pharmacologic treatments for
problem alcohol consumption can serve as an effective adjunct to non-pharmacologic treatments to
help patients reduce or eliminate alcohol consumption. The advance in the understanding of the
neurobiology of alcohol dependence and success of pharmacotherapy in other addictions has supported
the use of pharmacotherapy to help in the treatment of problem drinking. The lack of awareness
among clinicians that effective pharmacotherapy options exist is a primary reason for low utilization of
pharmacotherapy in clinical practice.
Current approved medications for alcohol use disorders include acamprosate, disulfiram, oral
naltrexone, and injectable naltrexone. Several other medications (e.g., topiramate) also show promise
in the treatment of alcohol use disorders. Similarly, buprenorphine has been effective at improving the
treatment of opioid dependence in office-based settings. Opioid agonist therapy (OAT) has historically
been restricted to delivery in licensed opioid agonist treatment programs (OATPs).
In 2002, sublingual buprenorphine and buprenorphine/naloxone tablets (hereafter collectively termed
buprenorphine) were approved for OAT. Buprenorphine has been shown to be a safe and effective
treatment of opioid dependence in non-specialized, outpatient, office-based settings (Fiellin et al.,
2006).
BACKGROUND
The provider in general healthcare settings can and should provide evidence-based medical
management to reduce substance use. A structured, focused format can provide an initial pathway
towards recovery. Brief interventions are effective in the initial phase and may be repeated as part of
medical monitoring. For patients who do not respond to brief intervention, comprehensive medical
management and monitoring as well as opportunistic referral to specialty SUD care are the emphases
of general healthcare treatment. In some cases, medical management will lead to remission of the
SUD or referral for specialty SUD care, while in others it serves a more palliative function.
RECOMMENDATIONS
1. Provide a brief intervention (counseling) for Unhealthy Alcohol Use , which includes the
following components: [A]
a. Express concern that the patient is drinking at unhealthy levels known to increase his/her
risk of alcohol-related health problems
b. Provide feedback linking alcohol use and health, including:
• Personalized feedback (i.e., explaining how alcohol use can interact with the
patient’s medical concerns [e.g., hypertension, depression/anxiety, insomnia,
injury, diabetes, breast cancer risk, interactions with medications]) OR
• General feedback on health risks associated with drinking.
c. Advise:
• To abstain (if there are contraindications to drinking) OR
• To drink below recommended limits (specified for the patient by gender, age
and health status)
d. Support the patient in choosing a drinking goal, if he/she is ready to make a change.
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2. Provide medical management in the treatment of alcohol use disorder and consider medical
management for other substance use disorders that includes: [C]
• Monitoring self-reported use, laboratory markers and consequences
• Use of medication, adherence monitoring, response to treatment and adverse effects
• Education and referral to community support for recovery (e.g., Alcoholics Anonymous).
3. Offer referral to a specialty addictions program when indicated.
RATIONALE
A number of modalities of psychosocial therapy have been studied and validated for treatment of
SUDs (McCaul & Petry, 2003). Referral to specialty care is an ongoing consideration for arranging
access to more extensive evidence-based psychosocial therapy interventions. In the context of the
primary care setting, delivering particular psychosocial therapies may be difficult due to time
constraints, patient population, and lack of training. Brief interventions and comprehensive medical
management and monitoring have been shown to be the most studied (and effective) interventions in
the context of non-specialty care settings (Anton et al. 2006).
Brief interventions (see discussion Module A, Annotation F).
Medical Management strategy was developed as part of the NIAAA-supported COMBINE study to
provide a basic form of clinical intervention supporting effective pharmacotherapy (Anton et al.,
2006). Medical Management is a manualized treatment designed to approximate a primary care
approach to alcohol dependence (http://pubs.niaaa.nih.gov/publications/combine/index.htm) (Pettinati
et al., 2000). The treatment, delivered by a medical professional (e.g., nurse or physician), provides
strategies to increase medication adherence and monitoring of substance use and consequences as well
as supporting abstinence through education and referral to support groups.
The initial session (40–60 minutes) involves discussion of the alcohol dependence diagnosis and
negative consequences from drinking, a recommendation to abstain, medication information, strategies
to enhance medication adherence, and referral to support groups such as Alcoholics Anonymous. In the
subsequent monitoring visits, the clinician assesses the client’s drinking, monitoring lab or physiologic
measures, assesing overall functioning, medication adherence, and any medication side effects.
Session structure varies according to the client’s drinking status and treatment compliance. When the
client does not adhere to the medication regime, the clinician evaluates the reasons and helps the client
devise plans to address the problem(s). Clinicians urge clients who drink to attend support groups and
offer common sense recommendations, such as avoiding bars. If the client suffers from medical side
effects, the clinician specifies procedures for using concomitant medication to ameliorate them or
reduces the dosage of either one or both study agents, resuming the study agents if side effects remit.
If a client discontinues medication because he or she cannot tolerate it, the clinician schedules a
monthly 15- to 25-minute “medical attention” meeting, during which the clinician employs a similar
approach that focuses on the client’s drinking and overall health, omitting the medication adherence
component.
In COMBINE, Medical Management appeared to be an excellent treatment to reduce alcohol
consumption even when the medication prescribed was placebo. Medical management can be adapted
to help treat substances other than alcohol use and alcohol use disorders, although further studies will
be required to support its effectiveness.
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EVIDENCE TABLE
BACKGROUND
Psychosocial rehabilitation services can be an important part of the treatment of SUD when indicated.
Negative life events and stressful circumstances may contribute to the onset or relapse of a substance
use disorder. They also may influence treatment adherence and outcome.
RECOMMENDATIONS
1. Referral to psychosocial rehabilitation services should be offered to individuals with identified,
unmet psychosocial needs, regardless of the population or setting, and regardless of the type of
pharmacotherapy or psychotherapy being administered.
2. Prioritize and address other coexisting biopsychosocial problems with services targeted to these
problem areas, rather than increasing intensity of addiction-focused psychosocial treatment alone.
[B]
a. Address transitional housing needs to facilitate access to treatment and promote a
supportive recovery environment
b. Provide social/vocational/legal services in the most accessible setting to promote
engagement and coordination of care
c. Address deferred problems as part of treatment plan updates and monitor emerging needs
d. Coordinate care with other social service providers or case managers.
DISCUSSION
The Guideline for Detoxification and Substance Abuse Treatment: An Overview of the Psychosocial
and Biomedical Issues during Detoxification (SAMHSA, 2006) recommends the following:
“Patients are more likely to engage in treatment if they believe the full array of their problems
will be addressed, including those needs typically addressed by social services (e.g., housing,
vocational assistance, childcare, and transportation). Moreover, patients receiving needed
services remain in substance abuse treatment longer and improve more than people who do
not receive such services.
As the individual passes through acute intoxication and withdrawal, it is important to ensure
that the basic needs of the patient are met after discharge. These needs include access to a
safe, stable, and drug-free living environment if possible; physical safety; food and clothing;
ongoing health and prenatal care; financial assistance; and childcare.
Providers should be familiar with available resources for legal assistance, dental care, support
groups, interpreters, housing assistance, trauma treatment, recovery-sensitive parenting
groups, spiritual and cultural support, employment assistance, and other assistance programs
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for basic needs. Family and other support systems also can be helpful to the patient in
accessing services and should take part in the services planning as often as possible, always
with the patient's consent.
To address the needs of homeless and indigent patients, providers should be familiar with
emergency shelters, cash assistance, and food programs in their communities and should have
established referral relationships. Assessing women, teenagers, older adults, and other
vulnerable individuals for victimization by another member of the household also is
important. Patients should be linked with prenatal and primary healthcare for domestic
violence. Ideally, linkage to these programs includes more than a phone number; and should
assist patients in scheduling initial appointments and arranging for transportation.”
BACKGROUND
In addition to the standard addiction-focused services, providers should address psychiatric and general
medical conditions that exist in association with the SUD. Treatment services directed toward these
additional problems, when they exist, are associated with improvement. Problems typically show little
spontaneous improvement if services are not provided.
RECOMMENDATIONS
1. Prioritize and address co-occurring medical and psychiatric conditions.
2. Recommend and offer cessation treatment to patients with nicotine dependence. Use the Clinical
Practice Guideline: Treating Tobacco Use & Dependence: 2008 Update from the U.S.
Department of Health and Human Services at:
http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf and the VA/DoD Clinical
Practice Guideline for Management of Tobacco Use.
3. Treat concurrent psychiatric disorders consistent with VA/DoD clinical practice guidelines (e.g.,
Major Depressive Disorder, Post Traumatic Stress, Bipolar Disorder, Psychoses) including
concurrent pharmacotherapy.
4. Provide multiple services in the most accessible setting to promote engagement and coordination
of care.
5. Monitor and address deferred problems and emerging needs through ongoing treatment plan
updates.
6. Coordinate care with other providers.
DISCUSSION
A comprehensive medical approach to medical care that addresses all of the patient’s co-occurring
disorders (CODs) is important. Patients benefit from a focused summary of their current SUD and the
effect that it has on their overall health as well as the effect it has on those around them. Collaboration,
service and system integration, when available, can assist in managing a patient with SUD and CODs.
Disease-specific treatment has been shown to be efficacious for patients diagnosed with SUD or other
psychiatric disorders alone. While there have been a number of theories about how to treat COD
among patients with SUD, there has been little data to support the best approach. In the simplest
sense, existing efficacious treatment that successfully reduces psychiatric symptoms in patients with
such symptoms alone should also reduce psychiatric symptoms in patients with both psychiatric CODs
and SUD. A review of 59 studies (36 RCTs evaluating treatment of dual diagnosis) concluded that
although no treatment was identified as efficacious for both psychiatric disorders and substance-related
disorder, the author found: (1) existing efficacious treatments for reducing psychiatric symptoms also
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tend to work in dual-diagnosis patients, (2) existing efficacious treatments for reducing substance use
also decrease substance use in dually diagnosed patients, and (3) the efficacy of integrated treatment is
still unclear (Tiet & Mausbach, 2007).
This is likely also true for medical CODs among SUD patients. There is scant literature on COD
treatment among patients with SUD. One meta-analysis on the use of medications to reduce
depressive symptoms in individuals with SUD concluded that antidepressants are effective for
reducing depressive symptoms among these patients, although the effect of these medications on the
substance use was limited. The existing literature regarding treatments for patients with SUDs with a
COD of major depression or bipolar disorders seems to support that medication, psychosocial, and
self-help treatments are available and show some evidence of effectiveness, but suggest that more
evidence is needed to demonstrate efficacious treatment effects for patients with CODs.
A growing body of research demonstrates that integrated services produce better outcomes for
individuals with CODs, particularly those with more serious or complex conditions. Integrated service
is any process by which mental, medical health, and SUD services are integrated or combined at either
the level of direct contact with the patients with COD or between providers or programs serving COD
patients. Providers in non-specialty care settings should communicate regularly and integrate their
care with specialty addiction care services when possible. For patients who are managed entirely
within non-specialty care settings, comprehensive COD and SUD care should be attempted. Often for
a primary care provider who is managing SUD, discussions with and/or referrals to behavioral
healthcare can be an important intervention for a patient with SUD. Likewise a behavioral health
specialist may find that collaborating with the primary care provider on the management of the medical
conditions of the patient may optimize the behavioral health provider’s attention to SUD care.
Motivation for SUD treatment can be increased when attention is paid to CODs.
Coordinated, collaborative overview of treatment options and processes to arrive at a plan of treatment
should occur with every patient with SUD and a COD. Unmanaged co-morbidities have a
demonstrated adverse effect on recovery from SUD. The non-specialty care setting is well suited for
coordinating and delegating the management of SUD, a COD, or both.
Substance use disorders often follow a chronic, relapsing course, making individualized treatment
more complicated (McLellan et al., 1996; O’Brien & McLellan, 1996). Treatment has not yet been
well-conceptualized for many patients who either have responded with minimal improvement to
repeated rehabilitative treatments or are unable or unwilling to engage in rehabilitation efforts, but who
desire other services. Even when patients are unable and/or unwilling to participate in rehabilitation or
show minimal benefit, there are opportunities to address SUD in other care settings.
Care management approaches for SUD are similar to management of other severe and persistent
disorders for which no cure has been identified, such as bipolar disorder or diabetes mellitus (McLellan
et al., 2000). Recent evidence suggests that approaches emphasizing engagement with the patient over
long periods of time, case management, and integration of substance abuse treatment interventions
with treatment for the coexisting conditions result in reduced substance use and associated
complications (Drake & Mueser, 2000; Osher & Drake, 1996; U.S. DHHS, 1994; Willenbring et al.,
1995; Willenbring et al., 1999). In the absence of serious co-morbidity or with appropriate specialist
consultation, care management can be provided within some addiction treatment clinics.
Even when patients refuse referral or are unable to participate in specialized addiction treatment, many
are accepting of general medical or psychiatric care. Clinicians in multiple settings can deliver care
management for patients with SUDs. The chronic illness approach is consistent with management
approaches for many other disorders treated in medical and psychiatric settings (Drake & Mueser,
2000; McLellan et al., 2000; Willenbring et al., 1999).
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EVIDENCE TABLE
BACKGROUND
Periodic monitoring of progress toward treatment goals helps to coordinate care and to motivate the
patient and members of the treatment team to accomplish interim steps. Periodic reassessments also
provide opportunities to address emerging problems and change treatment strategies when the initial
plan is not fully successful.
There is no uniformly successful treatment plan. Some patients may respond to psychosocial
interventions, others to pharmacotherapy. Some patients may respond to one medication and not to
another. The provider should be flexible in modifying the medical regimen based on the patient’s
needs or preferences.
RECOMMENDATIONS
1. Reassess response to treatment periodically and systematically, using standardized and valid
instrument(s) whenever possible. Indicators of treatment response include ongoing substance use,
craving, side effects of medication, emerging symptoms, etc.
2. Consider obtaining biological markers of recent substance use.
3. Assess co-occurring medical problems associated with substance use through history, physical
exam and appropriate laboratory evaluation.
DISCUSSION
Reassessments must occur at predictable intervals to enable both the decision about conservation of
resources and the acknowledgment that the SUD require assiduous attention. Periodic intervals may
include: after specialty care, after special studies, at agreed-upon milestones, and whenever the patient
or a collaborator report a deteriorating course.
The assessment in a medical setting involves at least two components: biomarkers and patient reports.
Biomarkers are objective evidence that an individual may be using drugs. These markers can be as
simple as a urine drug screen or physical indications of potential harm associated with use (e.g., liver
function abnormalities). Patient reports are based on questionnaires designed to get a "big picture" of
the patient's substance use and to identify potential "red flags" that require particular physician
attention. In the DoD setting, the Substance Use Report (SUR) measures the subject’s report of days
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of recent drug use and routes of administration. The use of methamphetamines, cocaine, alcohol,
marijuana, opioids, benzodiazepines, barbiturates, and nicotine (cigarette smoking) are recorded on
this form at each clinic visit.
L. Follow-Up
ACTION STATEMENT
For many patients, substance use disorders are chronic conditions that warrant extended efforts at
relapse prevention and encouragement by multiple providers for progress.
RECOMMENDATIONS
1. Ask the patient about any use, craving, or perceived relapse risk.
2. Provide feedback to patient regarding improvement or deterioration in laboratory assessments
affiliated with substance use.
3. Encourage abstinence or reduced use, consistent with the patient’s motivation and agreement.
4. Convey openness to discuss any future concerns that may arise and encourage the patient to
discuss them with you.
BACKGROUND
Expert opinion supports optimistic, empathetic interventions that note the importance of the changes
patients have made to their health, provide positive feedback and encourage continued drinking below
recommended limits.
RECOMMENDATIONS
1. Discuss the patient’s current use of alcohol and other drugs and address any potential problem
areas, such as recent initiation of use, increase in use, and use to cope with stress.
2. Inform patient about potential age- and gender-related problems, such as:
a. Abusive drinking or other drug use in the young adult
b. Alcohol and other drug use during pregnancy
c. Medication misuse or heavy drinking in the older adult.
3. Convey openness to discuss any future concerns that may arise and encourage the patient to
discuss them with you.
4. Periodically inquire about alcohol and drug use at future visits.
BACKGROUND
Patients’ goals may change over time, and providers should adapt to new objectives that the patient
may express. Partial remission may be common and requires an ongoing reevaluation of the treatment
plan rather than evidence that the patient cannot succeed or that the patient was not sufficiently
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motivated. Even after examining the reasons for partial remission and intensifying or modifying
psychosocial treatment or pharmacotherapy, some patients may not reduce alcohol consumption.
Treatment of chronic relapsing patients is difficult. For those willing to accept referral, treatment
should be undertaken by addiction professionals in specialty treatment settings that employ a multi-
faceted approach incorporating social, environmental, medical, behavioral, and motivational
interventions.
RECOMMENDATIONS
1. For patients who are not improving a consideration should be given to either:
a. Changing to another medication or intervention; or
b. Changing treatment intensity by:
• Increasing the intensity of care, or
• Increasing the dose of the medication, or
• Adding a medication.
2. For patients who do not stabilize and refuse to engage in any type of ongoing care with any
provider (e.g., medical, psychiatric, or addiction specialty) episodic attention to substance use may
be accomplished by the following:
a. Provide crisis intervention, as needed
b. At any contact initiated by the patient:
• Assess current substance use
• Recommend that the patient accept ongoing care in the most appropriate setting
• Designate a single provider to coordinate care for patients who repeatedly
present in crisis
• Consider involving supportive family members or significant others, if the
patient agrees. For DoD active duty members this may include first line
supervisor when appropriate, and will necessarily include the unit commander
• Initiate involuntary treatment procedures, if imminent threat to safety occurs
(e.g., suicidal, violent, or unable to care for self).
c. Continue to reinforce and endorse increased appropriate engagement and adherence.
3. Consider consultation with mental health or SUD specialty.
DISCUSSION
Indications to change treatment intensity or provide adjunctive treatments may include:
• Relapse based on self-report or urine toxicology
• Increased risk of relapse (e.g., craving or personal loss)
• Emergence or exacerbation of co-occurring medical and psychiatric conditions
• Suboptimal response to current treatment
• Emergence of medication side effects
• Subsequent substance-related misconduct.
Discuss relapse as a signal to reevaluate the treatment plan rather than evidence that the patient cannot
succeed or was not sufficiently motivated (Miller & Rollnick, 1991).
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BACKGROUND
Patients managed within this module meet the criteria for DSM-IV-TR substance abuse or dependence
and are considered for addiction-focused pharmacotherapy.
BACKGROUND
Addiction focused pharmacotherapy is often indicated for patients who meet DSM-IV-TR opioid
dependence criteria. The American Academy of Pain Medicine, the American Pain Society, and the
American Society of Addiction Medicine issued a consensus statement that distinguished addiction
from physical dependence. References to opioid dependence elsewhere in this module are based on
the diagnostic condition reflecting addiction rather than physical dependence alone.
See Introduction: Definitions (page 6)
RECOMMENDATIONS
1. Assess opioid dependence using DSM-IV-TR criteria.
.
PHARMACOTHERAPY FOR OPIOID DEPENDENCE
C. Is Opioid Agonist Treatment (OAT) Medication Appropriate for, and Acceptable to, the Patient?
BACKGROUND
Opioid agonist treatment (OAT) is the first line treatment for chronic opioid dependence that meets
DSM-IV-TR criteria. For DoD active duty members, OAT is generally not a treatment option.
RECOMMENDATIONS
1. Provide access to opioid agonist treatment (OAT) for all opioid dependent patients, under
appropriate medical supervision and with concurrent addiction-focused psychosocial treatment as
indicated. [A]
2. Strongly recommend methadone or sublingual buprenorphine/naloxone maintenance as first line
treatments due to their documented efficacy in improving retention and reducing illicit opioid use
and craving. [A]
3. Note: In pregnancy, buprenorphine monotherapy is preferred.
See Table P-1 for indications, contraindications, side effects, and drug interactions of methadone and
sublingual buprenorphine/naloxone.
Refer to Appendix C: Addiction-Focused Psychosocial Treatment
.
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DISCUSSION
Opioid dependence is a cluster of cognitive, behavioral, and physiological symptoms characterized by
repeated self-administration and usually results in opioid tolerance, withdrawal symptoms, and
compulsive drug taking, despite negative consequences. While federal regulatory language uses the
term “opiate addiction,” the diagnostic term opioid dependence will be used here for consistency with
the rest of the guideline. Dependence may occur with or without the physiological symptoms of
tolerance and withdrawal. OAT for opioid dependence consists of administering an opioid agonist
medication, such as methadone or sublingual buprenorphine, in combination with a comprehensive
range of medical, counseling, and rehabilitative services. By administering an opioid to prevent
withdrawal, reduce craving, and reduce the effects of illicit opioids, the opioid dependent patient is
able to focus more readily on recovery activities. In addition, OAT has been associated with a
reduction in human immunodeficiency virus (HIV) risk behavior, and drug-related criminal behavior
When compared to medically supervised withdrawal attempts, OAT is more successful in achieving
the long-term goal of reducing opioid use and the associated negative medical, legal, and social
consequences.
Two systematic reviews examined the efficacy of buprenorphine versus methadone for opioid
maintenance therapy. Mattick et al. (2003) concluded that buprenorphine can reduce heroin use but is
not as effective as methadone. Buprenorphine given in flexible doses was less effective than
methadone in retaining patients in treatment (6 RCTs, N=837, RR=0.82; 95%CI: 0.69-0.96). There
was no advantage for high dose buprenorphine over high dose methadone in retention (5 RCTs,
N=449, RR=0.79; 95%CI: 0.62-1.01). Farre et al. (2002) found that low doses of buprenorphine were
not as effective as high doses of methadone for risk of illicit drug use (OR 3.39, 95%CI, 1.87-6.16).
Since the publication of the above systematic reviews, RCTs of buprenorphine versus methadone have
suggested that methadone was more effective at reducing opioid consumption (Fischer et al., 2006;
Neri et al., 2005). One trial suggested that methadone may also be superior to buprenorphine for
maintenance of patients with co-occurring cocaine dependence (Schottenfeld et al., 2005). When
reported, retention rates in these trials ranged from 59 to 93 percent, and relapse rates from 16 to 28
percent.
Table P- 1. Agonist Therapy for Opioid Dependence
Methadone Buprenorphine / Naloxone or Buprenorphine
Indications Opioid dependence (DSM diagnosis) and Opioid dependence (DSM diagnosis) plus one or
patient meets Federal Opioid Treatment more of the following:
Standards (42 CFR 8.12) 1 New patients not currently receiving OAT
AND who meet at least one of the following
3 criteria:
a. Do not have timely access to a VA-
supported OAT center.
b. Do not meet regulatory criteria for
treatment in an OAT program.
(http://www.dpt.samhsa.gov/)
c. Will have difficulty adhering to
scheduled visits at a VA supported
OAT program (e.g., because of
restrictive clinic hours).
2 Appropriately selected patients on stable
methadone maintenance who have difficulty
adhering to scheduled visits at a VA-
supported OAT center or may not need
close supervision.
3 Patients who have a documented severe,
uncontrollable adverse effect or true
hypersensitivity to methadone.
Contraindications Hypersensitivity Hypersensitivity
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Cardiac arrhythmias with prolonged QTc Use of opioid antagonists (e.g., naloxone,
nalmefene, or naltrexone)
interval
Dosage and Initial dose: 15–20 mg single dose, max. Induction dose: 2–8 mg sublingually once daily
Administration 30 mg. Day 2 and onward: Increase dose by 2–4 mg/d;
Daily dose: Max. 40 mg/d on first day. target dose in first week, 12–16 mg/d.
Usual dosage range for optimal effects:
Stabilization / Maintenance: Titrate by 2–4 mg
60–120 mg/d. per week; usual dose 12–16 mg/d (up to
Titrate carefully, consider methadone’s 32 mg/d)
delayed cumulative effects Individualize dosing regimens
Give orally in single dose
Individualize dosing regimens (AVOID
same fixed dose for all patients)
Alternative Dosing Give in divided daily doses based on peak Give equivalent weekly maintenance dose
Regimens and low levels that document a divided over extended dosing intervals (2 or 3
metabolic rate that justifies divided times a week or every 2, 3, or 4 days)
doses
Dosing in Special Renal or Hepatic Impairment: Reduce Hepatic Impairment: Reduce dose
Populations dose
Elderly or Debilitated: Reduce dose
Adverse Effects Major: respiratory depression, shock, Major: hepatitis, hepatic failure, respiratory
cardiac arrest, possible prolongation of depression (usually when misused
QTc interval on ECG and torsades de intravenously with other CNS depressants)
pointes ventricular tachycardia Common: headache, pain, abdominal pain,
Common: lightheadedness, dizziness, insomnia, nausea, vomiting, sweating,
sedation, nausea, vomiting, sweating, constipation
constipation, edema
Less common: sexual dysfunction
Drug Interactions Drugs that reduce serum methadone levels: Drugs that reduce serum buprenorphine level:
ascorbic acid, barbiturates, ascorbic acid, barbiturates, carbamazepine,
carbamazepine, ethanol (chronic use), ethanol (chronic use), interferon, phenytoin,
interferon, phenytoin, rifampin, rifampin, efavirenz, nevirapine, other
efavirenz, nevirapine, other antiretrovirals with CYP3A4 activity
antiretrovirals with CYP3A4 activity Drugs that increase serum buprenorphine level:
Drugs that increase serum methadone amitriptyline, atazanavir,
level: amitriptyline, atazanavir, atazanavir / ritonavir, cimetidine, delavirdine,
atazanavir / ritonavir, cimetidine, diazepam, fluconazole, fluvoxamine,
delavirdine, diazepam, fluconazole, ketoconazole, voriconazole
fluvoxamine, ketoconazole, Opioid agonist: buprenorphine/naloxone or
voriconazole
buprenorphine may precipitate withdrawal
Opioid antagonists may precipitate Opioid antagonists may precipitate withdrawal
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withdrawal
Patient Education Strongly advise patient against self- Strongly advise patient against self-medicating
medicating with CNS depressants with CNS depressants during buprenorphine
during methadone therapy therapy
Serious overdose and death may occur if Serious overdose and death may occur if
benzodiazepines, sedatives, benzodiazepines, sedatives, tranquilizers,
tranquilizers, antidepressants, or alcohol antidepressants, or alcohol are taken with
are taken with methadone buprenorphine
Store in a secure place out of the reach of Store in a secure place out of the reach of
children children
EVIDENCE TABLE
Evidence Source QE Overall Net SR
Quality Effect
1 Methadone and buprenorphine Farre et al., 2002 I Good Subst A
are efficacious in decreasing Fischer et al., 2006
opioid use. Johnson et al., 2000
Lintzeris et al., 2004
Marsch, 1998
Mattick et al., 2003
Neri et al., 2005
Schottenfeld et al., 2005
Strain et al., 1993a, 1993b
2 Methadone may be slightly Farre et al.,, 2002 I Good Subst A
more efficacious than Fischer et al., 2006
buprenorphine in decreasing Mattick et al., 2003
opioid use, particularly in Neri et al., 2005
patients with co-occurring Schottenfeld et al., 2005
cocaine dependence.
3 Methadone may be slightly Mattick et al., 2003 I Good Subst A
more efficacious than
buprenorphine in retaining
patients in treatment.
QE = Quality of Evidence; Net effect = Significance of the intervention benefit; SR = Strength of Recommendation
(See Appendix A)
D. Is Treatment in a Specialized Opioid Agonist Treatment Program (OATP) Setting Appropriate for
the Patient?
BACKGROUND
In general, patients requiring greater structure and intensity of comprehensive treatment services
including mental health, medical, and social services, may be better served in an Opioid Agonist
Treatment Program (OATP). Provision of care at OATPs is highly regulated, with provider and
patient-level requirements including limited take home medications provided, mandated laboratory
studies and clinical assessments, appropriate psychosocial intervention, and formal agreements for the
provision of OAT. In office-based opioid treatment (OBOT) for medical maintenance by credentialed
physicians, patients usually receive less intensive services (e.g., less psychosocial services needed to
prevent relapse) either within an addiction specialty care program or in a setting similar to treatment of
other medical conditions.
Deciding on whether a patient requires opioid agonist treatment in a specialized OATP depends on
matching treatment resources to each individual patient’s needs.
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RECOMMENDATIONS
1. Individualize the choice of setting based on patient characteristics and availability of facilities to
treat patients with opioid agonist therapy (OAT). See Table P-2.
2. Appropriate psychosocial interventions should be provided as part of the opioid agonist therapy
(OAT). [A]
DISCUSSION
Opioid agonist therapy (OAT) can be delivered through opioid agonist treatment program (OATP) or
through office-based treatment (OBOT). OATPs are structured, licensed facilities that are not
available to each VHA facility. However, OATPs, or “methadone facilities,” may be located in
proximity to a VHA or near the veterans domicile. Most OATPs provide both medically supervised
withdrawal and rehabilitation services. Most OATPs provide comprehensive services including
individual therapy, group therapy, and family counseling. OATPs can provide OAT in the form of
methadone and buprenorphine. Most OATPs are providing predominantly methadone. Provision of
care at OATPs is highly regulated, with provider and patient-level requirements including limited take
home medications provided, mandated laboratories and assessments, appropriate psychosocial
intervention, and formal agreements for the provision of OAT.
OBOT for opioid dependence can only be provided by credentialed physicians. Buprenorphine is the
only medication approved for OBOT. Minimum resources necessary to provide OBOT using
buprenorphine include history and physical exam, availability to obtain laboratories including urine
drug testing, and access to additional counseling and treatment services. OBOT using buprenorphine
can be provided in residential and outpatient arrangements and any environment not directly associated
with OATP. If providing buprenorphine within the confines of an OATP, all OATP
requirements/regulations must be met.
Fiellin et al. (2006) randomized subjects to one of 3 conditions: 1) one 45 minute counseling session
per week plus thrice weekly buprenorphine dispensing; 2) one 20 minute counseling session per week
plus thrice weekly buprenorphine dispensing; 3) one 20 minute counseling session per week plus once
weekly buprenorphine dispensing. Outcomes (illicit opioid use and treatment retention) did not differ
by condition. Thus, a more intensive amount of psychosocial treatment was not better than a modest
amount of psychosocial treatment.
Peer reviewed evidence evaluating system-, provider-, or patient-level factors that would assist the
provider in determining whether a patient is most appropriate for OATP or OBOT care is currently not
available, but several principles apply. If the facility has access to an OATP, and the patient is willing
to accept OAT care through the OATP, patients should be directed to explore OATP care. If the
facility does not have access to an OATP, OBOT care should be available. Patient level factors that
would steer a provider to recommend an OATP over OBOT are the following: pregnancy (high level
evidence), severe opioid dependence (high-mod evidence), co-existing pain syndromes requiring
opioids (high level of evidence), and social/environmental instability (low level of evidence).
Currently, the “gold standard” treatment of a pregnant opioid dependent patient is OATP care using
methadone. This care has significant history, is well known to most providers, and has much evidence
for efficacy for the mother, fetus and newborn. Patients who use significant amounts of opioids and
who have a high level of physical dependence and tolerance may be better treated with methadone
through an OATP (moderate level of evidence). Patients who have co-occurring pain syndromes,
requiring OAT and opioids for pain control should be treated within an OATP as concurrent use of
opioid medications for pain and buprenorphine presents management challenges and may be
ineffective. Social and environmental factors (e.g., homelessness, marital discord, dangerous living
environments) may prompt a provider to suggest OATP over OBOT care as OATP care generally has
more access to wrap around services that may assist in the patient recovery (e.g., vocational training,
housing assistance, family counseling). Recent evidence suggests that OBOT can be provided with
success to the homeless and patients with social/environmental stressors, but OATP care is likely the
preferred choice.
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A systematic review (Amato et al., 2004) concluded that adding any psychosocial support to standard
methadone maintenance therapy reduced the use of heroin during treatment. Based on eight studies
(N=510) the relative risk for retention in treatment was 0.94 (95%CI 0.85 to 1.02), and based on three
studies (N=250) the relative risk for abstinence at the end of follow-up was 0.90 (95%CI 0.76 to 1.07).
While these findings showed a trend towards improved outcomes by adding any psychosocial support,
they did not reach statistical significance.
Scherbaum et al. (2005) compared methadone plus psychosocial intervention (cognitive behavioral
training [CBT]) versus methadone alone. This RCT found a significant difference in drug use between
methadone plus CBT versus methadone alone. Retention rates were 63 percent and 59 percent, and
abstinence rates or percentage of negative urine were 29 percent and 52 percent respectively.
Patients who have difficulty accessing an OATP (e.g., large geographical distances, lack of
transportation) may be better treated in OBOT using buprenorphine. Recent evidence suggests that use
of buprenorphine may be preferable to methadone due to drug-drug interactions of medications taken
for co-occurring conditions (e.g., anti-retroviral medications for HIV). OBOT care using
buprenorphine may also be preferred over OATP care for patients with opioid dependence, but with
intermittent use of opioids and who do not have a significant amount of physical dependence and
tolerance of opioids.
Table P- 2. Patient Suitability for Office-Based Opioid Treatment versus Opioid Treatment Program*
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EVIDENCE TABLE
E. Initiate Opioid Agonist Treatment in an Opioid Agonist Treatment Program (OATP) or Office-
Based Opioid Treatment (OBOT)
RECOMMENDATIONS
Opioid Agonist Treatment Program (OATP) and office-based opioid treatment (OBOT) must be
provided in the context of a complete treatment program that includes:
a. Appropriate adjustment of opioid agonist doses to maintain a therapeutic range between
signs/symptoms of overmedication (e.g., somnolence, miosis, itching, hypotension, and
flushing) and opioid withdrawal (e.g., drug craving, anxiety, dysphoria, and irritability)
• Usual dosage range for optimal effects: 60–120 mg/day [A]
• Buprenorphine target dose is generally up to 16mg daily; doses above 32mg are
rarely indicated. In all cases, except pregnancy, the combination product of
buprenorphine/naloxone should be used.
b. Relapse monitoring to promote effective outcomes
c. Adequate frequency of toxicology for alcohol and other drugs of abuse. Drug testing for
both methadone and buprenorphine should also be considered to ensure compliance with
the prescription and for detection of possible diversion
d. Appropriate psychosocial interventions. [A]
DISCUSSION
Methadone Therapy
• Methadone for the treatment of opioid dependence may only be prescribed out of an
accredited OATP as it is a schedule II agent. It is illegal to prescribe methadone for the
treatment of opioid dependence out of an office-based practice.
• For newly admitted patients, the initial dose of methadone should not exceed 30 mg and the
total dose for the first day should not exceed 40 mg, without provider documentation that 40
mg did not suppress opioid withdrawal symptoms.
• Under usual practices, a stable, target dose is greater than 60 mg/day and most patients will
require considerably higher doses in order to achieve a pharmacological blockade of
reinforcing effects of exogenously administered opioids.
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Buprenorphine Therapy
• Office-based treatment with sublingual buprenorphine for opioid dependence can only be
provided by physicians who have received a waiver from the SAMHSA and have a special
DEA number. “To qualify for a waiver under DATA 2000, a licensed physician (MD or DO)
must meet any one or more of the following criteria:
o The physician holds a subspecialty board certification in addiction psychiatry from
the American Board of Medical Specialties.
o The physician holds an addiction certification from the American Society of
Addiction Medicine.
o The physician holds a subspecialty board certification in addiction medicine from the
American Osteopathic Association.
o The physician has, with respect to the treatment and management of opioid-addicted
patients, completed not less than eight hours of training (through classroom
situations, seminars at professional society meetings, electronic communications, or
otherwise) that is provided by the American Society of Addiction Medicine, the
American Academy of Addiction Psychiatry, the American Medical Association, the
American Osteopathic Association, the American Psychiatric Association, or any
other organization that the Secretary (of Health and Human Services) determines is
appropriate for purposes of this subclause.
o The physician has participated as an investigator in one or more clinical trials leading
to the approval of a narcotic drug in schedule III, IV, or V for maintenance or
medically supervised withdrawal treatment, as demonstrated by a statement
submitted to the Secretary by the sponsor of such approved drug.
o The physician has such other training or experience as the State medical licensing
board (of the State in which the physician will provide maintenance or medically
supervised withdrawal treatment) considers to demonstrate the ability of the
physician to treat and manage opioid-addicted patients.
o The physician has such other training or experience as the Secretary considers to
demonstrate the ability of the physician to treat and manage opioid-addicted patients.
Any criteria of the Secretary under this subclause shall be established by regulation.
Any such criteria are effective only for 3 years after the date on which the criteria are
promulgated, but may be extended for such additional discrete 3-year periods as the
Secretary considers appropriate for purposes of this subclause. Such an extension of
criteria may only be put into effect through a statement published in the Federal
Register by the Secretary during the 30-day period preceding the end of the 3-year
period involved.”
Source: www.buprenorphine.samhsa.gov/waiver_qualifications.html
• For the first year a physician has her or his waiver, the physician may dispense or prescribe
buprenorphine for up to 30 patients at a time under the provisions of the Drug Addiction
Treatment Act of 2000 (DATA). After the first year the qualified physician can apply to
SAMHSA to raise her or his treatment limit to 100.
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EVIDENCE TABLE
BACKGROUND
Naltrexone is an FDA approved alternative to opioid agonist treatment for patients with opioid
dependence who are highly motivated and have psychosocial support for treatment and medication
adherence. However, the number of individuals maintained on naltrexone continues to be low and its
usefulness in the treatment of opioid dependency has been limited. It has no opioid agonist effects.
Patients may continue to experience cravings and may thereby not be motivated to maintain adherence
to the medication regimen. Patients addicted to opioids must be fully withdrawn for up to 7-10 days
from all opioids before beginning naltrexone treatment. Unfortunately, during this period, many
patients relapse to use of opioids and are unable to start on naltrexone.
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RECOMMENDATIONS
1. Consider monitored administration of naltrexone maintenance in highly motivated opioid
dependent patients. [C] See Table P-3.
2. Consider opioid agonist treatment (OAT) or long-term therapeutic community before naltrexone
as first line approaches for chronic opioid dependent patients.
Indications Opioid dependence with ability to achieve at least 7-10 days of abstinence to
prevent precipitated withdrawal with first dose
Engagement in comprehensive management program that includes measures to
ensure medication adherence
Note: Most effective when the patient is engaged in addiction-focused counseling
with monitored administration
Contraindications Acute hepatitis or liver failure
Hypersensitivity to naltrexone or product components
Current physiological dependence on opioids with use within past 7 days
Ongoing acute opioid withdrawal or failed naloxone challenge test
Receiving opioid agonists
Positive urine opioid screen
DISCUSSION
Naltrexone has no positive psychoactive effects and is unpopular with many opioid dependent patients
since naltrexone maintenance therapy requires complete abstinence from opioids. Treatment dropouts
are common. Naltrexone has been shown to be ineffective in preventing relapse when treatment
retention rates are low and moderately effective when retention and medication adherence are adequate
(Johansson et al., 2006).
Although the utility of naltrexone maintenance therapy is limited, some highly motivated patients—
those with strong incentives to complete treatment—can successfully prevent relapse using naltrexone
therapy. Subpopulations with better prognosis for response may include patients highly motivated for
abstinence without obvious external pressure; patients receiving contingency management to enhance
motivation (Adi et al., 2007); patients in the criminal justice system with monitored administration
(Cornish et al., 1997); business executives (Washton, 1984); and healthcare workers with employment-
related monitoring (Ling & Wesson, 1984).
There is inconsistent evidence for additional benefit of adding psychosocial treatment to naltrexone
therapy (relative to naltrexone therapy alone) and vice versa (adding naltrexone to psychosocial
treatment relative to psychosocial treatment alone) (Minozzi et al., 2006; Adi et al., 2007).
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EVIDENCE TABLE
Evidence Source QE Overall Net SR
Quality Effect
1 In opioid-dependent Adi et al., 2007 I Poor to Small C
patients post opioid Minozzi et al., 2006 Fair to
withdrawal, naltrexone is Johansson, 2006 Mod
effective in reducing
heroin/drug abuse;
however, its effectiveness
in preventing relapse
depends on patient retention
/ adherence.
2 Consider monitored Adi et al., 2007 I Poor Small I
administration of naltrexone
maintenance in highly
motivated opioid dependent
patients.
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
G. Assure Patient is Withdrawn from Opioids and Opioid Free Before Continuing
BACKGROUND
Avoid an adverse opioid withdrawal reaction precipitated by naltrexone during lingering physiological
dependence. Such reactions can result in extreme reluctance to trust treatment of any modality.
RECOMMENDATIONS
1. Prior to starting naltrexone, ensure that the patient is opioid-free as naltrexone is an opioid
antagonist and may precipitate withdrawal.
2. Consider pharmacologically assisted withdrawal (See Module S: Stabilization and Withdrawal
Management, Annotation F), unless the patient successfully completed a naloxone challenge
and/or has had at least 7-10 days of verified abstinence.
DISCUSSION
There are several methods to resolve uncertainty about physiological dependence on opioids:
• Self-report
• Urine toxicology screening
• Medical record review
• Physical examination (e.g., stigmata of IV use or symptoms of opioid withdrawal)
• Intoxication
• Confirming physiological dependence can also be accomplished with a challenge using
naloxone, a short acting narcotic antagonist, to elicit signs and symptoms of precipitated
withdrawal (O’Brien, 1994). A naloxone challenge should be done selectively and with great
care (e.g., by or in close consultation with a physician experienced in management of opioid
withdrawal) since patients can rapidly experience serious opioid withdrawal.
a. Give 0.2 to 0.4 mg of naloxone, subcutaneously or intravenously; if patient is
physiologically dependent on opioids, precipitated withdrawal usually begins within
minutes.
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b. Patients with low levels of opioid use may require up to a total dose of 0.8 mg of
naloxone to precipitate withdrawal, given in increments of 0.2 mg every 30 minutes.
c. Symptoms usually peak within 30 minutes and subside in 3 to 4 hours.
d. An oral dose of 5 or 10 mg of methadone may attenuate the withdrawal.
H. Initiate Naltrexone for Opioid Dependence with Patient Education and Monitoring
BACKGROUND
Patients who have successfully completed a naloxone challenge and/or have had at least 7 to 10 days
of verified abstinence and who lack contraindications can be safely started on naltrexone maintenance
therapy.
RECOMMENDATIONS
1. Provide appropriate dosing, treatment retention- and adherence-enhancing techniques, and relapse
monitoring to promote effective outcomes.
2. Carefully start oral naltrexone at a dose of 25 mg once daily. If no signs of withdrawal occur, the
dose may be increased to 50 mg daily on the following day. Extended dosing intervals, using
equivalent weekly doses, may be used for supervised administration (see Table P-4).
Dosage and 25 mg orally once daily initially; if no withdrawal reaction, increase to 50 mg once daily
Administration Observed administration improves adherence
Alternative Dosing - 25 mg orally twice daily with meals to reduce nausea, especially during the first week
Schedules - 100 mg on Monday and Wednesday, 150 mg on Friday
DISCUSSION
Only the oral formulation of naltrexone is currently FDA-approved for maintenance therapy of opioid
dependence. Treatment programs to prevent relapse, with or without naltrexone, often fail unless the
patient is motivated to adhere to treatment.
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BACKGROUND
For the purposes of this guideline, alcohol dependence is defined via DSM-IV-TR criteria.
RECOMMENDATION
1. Identify patients with alcohol dependence that should be considered for addiction-focused
pharmacotherapy.
See Introduction: Definitions (page 6)
BACKGROUND
Established pharmacologic treatments, notably disulfiram and naltrexone, (see Table P-5) combined
with addiction-focused counseling may reduce the amount of drinking, the risk of relapse, the number
of days of drinking, and craving in some alcohol-dependent individuals. For many patients, however,
these treatments are not effective. Research in molecular and behavioral genetics are guiding the
development of new drugs seeking to identify pharmacologic pathways relevant to alcohol dependence
and to more effectively match treatments to individuals according to their genetic characteristics.
Medications such as ondansetron, topiramate, sertraline, aripiprazole, quetiapine and baclofen
represent novel lines of research and are currently being tested for use in the treatment of alcoholism.
RECOMMENDATIONS
1. Routinely consider oral naltrexone, an opioid antagonist, and/or acamprosate for patients with
alcohol dependence. [A]
Note that in VA, acamprosate is currently a non-formulary medication with criteria for use posted
at http://vaww.national.cmop.va.gov/PBM/Clinical%20Guidance/Forms/AllItems.aspx
2. Medications should be offered in combined with addiction-focused counseling. [A]
3. Injectable naltrexone should be considered when medication adherence is a significant concern in
treating alcohol dependence and should be combined with addiction-focused counseling. [A]
Note that in VA, injectable naltrexone is currently a non-formulary medication with criteria for
use posted at http://vaww.national.cmop.va.gov/PBM/Clinical%20Guidance/Forms/AllItems.aspx
4. If patient does not respond to one of the approved medications, a trial on one of the other approved
medications is warranted.
5. Because of the risk of significant toxicity and limited evidence of effectiveness, risk and benefits
of disulfiram should be considered and disulfiram should only be used when abstinence is the goal
and when combined with addiction-focused counseling. [B] The informed consent discussion
with the patient should be documented.
6. Dosing of these pharmacotherapies should be consistent with medication trials and
recommendations in appropriate drug references (see Table P-5).
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DISCUSSION
Three drugs have been FDA-approved for adjunctive therapy in alcohol dependence: the opioid
antagonist naltrexone (oral and extended-release injectable), the putative glutamate antagonist
acamprosate, and the acetaldehyde dehydrogenase inhibitor disulfiram.
There is convincing evidence of the efficacy of naltrexone. In short-term trials (up to 12 weeks),
naltrexone was shown to decrease the risk of relapse in recently withdrawn alcohol-dependent patients
who concomitantly received addiction counseling (Anton, 2005; Bouza, 2004; Kranzler & Van, 2001;
Srisurapanont & Jarusuraisin, 2005; Streeton & Whelan, 2001). The effect size for relapse reduction is
small to moderate (RR 0.64; NNT = 7), but clinically meaningful. Naltrexone treatment was also
shown to decrease the likelihood of returning to drinking (RR 0.87; NNT = 13) (Srisurapanont
&Jarusuraisin, 2005), the likelihood of treatment discontinuation (RR 0.82, NNT = 13) (Srisurapanont
& Jarusuraisin, 2005), and the amount of alcohol consumed (Kranzler & Van, 2001; Pettinati et al,
2006; Streeton & Whelan, 2001). The efficacy of naltrexone in improving abstinence has been
inconsistent (Pettinati et al., 2006). Poor adherence to orally self-administered medications is one of
the major reasons for naltrexone treatment failure in alcohol-dependent patients. Therefore, methods
for enhancing medication adherence, such as psychosocial therapy and management of adverse effects,
should be used during oral naltrexone therapy.
One approach to enhancing patient adherence is to use the long-acting formulation of naltrexone.
Naltrexone extended-release suspension may be administered once monthly via intramuscular injection
by a healthcare professional. When given with low-intensity psychosocial therapy, a 6-month course
of therapy with this formulation was shown to decrease alcohol consumption (Johnson et al., 2004) and
moderately decrease heavy drinking (treatment effect size relative to placebo, 25%) in a population
consisting of mostly nondetoxified patients (Garbutt et al., 2005). A subset of patients with
pretreatment abstinence (≥ 7 days) had a greater decrease in heavy drinking (effect size, 80%) as
compared with nonabstinent patients (effect size, 21%) (O’Malley, 2007). Another depot formulation
of naltrexone was also shown to be efficacious in an early clinical trial (Kranzler et al., 2004).
Several systematic reviews support the efficacy of acamprosate. They showed that acamprosate
improves the likelihood of abstinence and retention in treatment in recently withdrawn patients (Bouza
et al., 2004; Kranzler & Van, 2001; Mann et al., 2004). In one good-quality systematic review, the
effect size for abstinence was small to moderate (OR 1.88; 95% CI, 1.57–2.25; NNT = 10; 95% CI, 7–
15) (Bouza et al., 2004). In another good-quality systematic review, acamprosate significantly
improved continuous abstinence rates at 6 months (relative benefit (RB) 1.47; 95% CI, 1.29-1.69; p <
0.001). The overall placebo-corrected difference in success rates at 12 months was 13.3% (95% CI,
7.8-18.7%; NNT = 7.5) (Mann et al., 2004).
There is a paucity of randomized placebo-controlled clinical trials supporting the use of disulfiram. A
multi-site partially VA study that compared 250 mg disulfirarm to 1 mg disulfiram and to a vitamin
pill found no differences in overall abstinence rates but did find significantly less alcohol use among
compliant subjects in the 250 mg group (Fuller et al., 1986). One study involving dual diagnosis
patients with Axis I psychiatric disorder and co-occurring alcohol dependence showed that open-label
disulfiram and blinded naltrexone were modestly effective and equivalent in reducing alcohol use, and
there was no additional benefit from using the combination over the individual medications (Petrakis et
al., 2005).
Injectable naltrexone should also be routinely considered as the initial therapy, as each extended-
release dose ensures medication adherence for a full month and, in contrast to oral naltrexone, there is
evidence of efficacy beyond three months and in non-withdrawn patients. Pretreatment with oral
naltrexone is not necessary to establish benefit or tolerability prior to starting intramuscular naltrexone.
Injectable naltrexone should also be considered in patients with poor adherence to oral medications.
No published trials have directly compared the injectable and oral forms of naltrexone in terms of
efficacy and safety.
Disulfiram should be considered more selectively because of its potential to cause serious
hepatotoxicity. Monitored administration significantly improves compliance. Disulfiram should be
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considered whenever a patient requests it or when some form of monitoring is available. In clinical
practice, it is sometimes used to provide additional support during periods of high risk of relapse.
Evidence for its efficacy in treatment of combined cocaine and alcohol dependence is relatively strong
(Carroll et al., 1998; McCance-Katz et al., 1998; George et al., 2000; Petrakis et al., 2000)
As summarized below, studies comparing naltrexone and acamprosate have shown inconsistent results.
Two studies have shown no significant differences between naltrexone and disulfiram. There is
insufficient evidence to support the routine use of one drug over another.
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EVIDENCE TABLE
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B. Obtain History, Physical Examination, Mental Status Examination (MSE), Medication Including
Over-The-Counter (OTC), and Lab Tests as Indicated
BACKGROUND
The provider should review or obtain clinical background information on the patient, including any
prior assessment.
RECOMMENDATIONS
1. Interview the patient and other collateral informants, where appropriate, about medical and mental
health history and use of prescription and non-prescription medications before initiating extensive
diagnostic testing.
2. Note any history of recent head trauma.
3. Order laboratory tests selectively, aiming to detect potential medical causes for the presenting
symptoms, where indicated by:
a. Specific symptoms found on the medical review of systems
b. Evidence of unusual symptom profiles
c. History of atypical illness course
d. Abnormal screen for cognitive status, particularly in the elderly patient.
DISCUSSION
Consider a standardized instrument, such as Folstein’s Mini-Mental State Examination (MMSE)
(Folstein et al., 1975) using age and education-adjusted cut-off scores (Crum et al., 1993), to assess for
cognitive status realizing that alcohol and other substances may impair the operating characteristics of
this test.
Screen for mental health disorders in patients who are under evaluation for use of alcohol and other
substances.
BACKGROUND
Emergency or urgent actions include unstable medical problems (e.g., acute trauma, myocardial
infarction, and stroke) or unstable psychiatric problems (e.g., imminent risk of harm to self and/or
others and delirium, including alcohol-related delirium [withdrawal/intoxication]).
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RECOMMENDATIONS
1. Refer patients with problems that require emergency care or urgent action to emergency care for
further action as needed.
DISCUSSION
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Acute intoxication
1. The most common signs and symptoms involve disturbances of perception, wakefulness,
attention, thinking, judgment, psychomotor behavior, and interpersonal behavior.
2. Patients should be medically observed at least until blood levels are decreasing and the clinical
presentation is improving.
3. Highly tolerant individuals may not show signs of intoxication. Patients may appear “sober” even
at blood alcohol levels (BAL) well above the legal limit.
4. Recent intake of a substance can be assessed from the history, physical examination (e.g., alcohol
on the breath), or toxicological analysis of urine or blood. The specific clinical picture in
substance intoxication depends on the substance(s) used, the duration of use at that dose,
tolerance, time since last dose, expectations of effects, and the environment or setting of use.
BACKGROUND
Existing local policies and procedures with regard to threats to self or others reflect local and state laws
and the opinion of the VA District Council and the DoD. Primary care, mental health, and
administrative staff must be familiar with these policies and procedures.
RECOMMENDATIONS
1. Assure the patient’s immediate safety and determine the most appropriate setting.
2. Refer for mental health treatment or assure that follow-up appointment is made.
3. Inform and involve someone close to the patient.
4. Limit access to means of suicide.
5. Increase contact and make a commitment to help the patient through the crisis.
6. For comatose patients, maintain airway and adequate ventilation in order to preserve respiration
and cardiovascular function.
7. Emergency procedures should be considered, including the use of gastric lavage for sedative,
hypnotic, and/or opioid intoxication.
8. Emergency pharmacologic interventions should be utilized as appropriate, including the use of
intravenous naloxone hydrochloride for opioid overdose and flumazenil for benzodiazepine
overdose.
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9. Agitation secondary to intoxication from a variety of substances is best initially managed through
interpersonal approaches and decreasing sensory stimuli rather than additional medications. If
chemotherapeutic agents are necessary, the short acting IM benzodiazepines (e.g., lorazepam) and
high potency neuroleptics should be considered
For DoD active duty members: follow DoD and Service-specific policies, as mental
health/emergency referral is likely mandated.
DISCUSSION
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
2 Note increased risk for violence. Hasting & Hamberger, 1997 III Poor I
Thienhaus & Piasecki, 1998
3 Offer counseling to a patient at Hirschfield & Russello, 1997 III Poor I
risk. USPSTF, 1996
4 Arrange emergency treatment or APA, 1993 III Poor I
possible hospitalization. US DHHS, 1993 & 1995
USPSTF, 1996
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
E. Assess Level of Physiological Dependence and Indications for Stabilization Including Risk of
Withdrawal
BACKGROUND
Untreated severe alcohol and other sedative-hypnotic withdrawal, in particular, can lead to autonomic
instability, seizures, delirium, or even death.
The opioid withdrawal syndrome can be protracted with intense symptoms, though the syndrome itself
poses virtually no risk of mortality. However, there is significant mortality risk from overdose for
those who relapse following unsuccessful medically supervised withdrawal attempts as a result of loss
of opioid tolerance.
The potential for a withdrawal syndrome can be gauged only imprecisely by asking the patient the
pattern, type, and quantity of recent and past substance use. Systematic monitoring of withdrawal
symptoms is indicted until patients are stabilized.
RECOMMENDATIONS
1. Obtain and document necessary information to classify level of withdrawal and factors that may
influence the severity of the withdrawal (see Appendix B-6 for a list of withdrawal signs and
symptoms for the different types of substances):
a. Determine type of substance of use
b. Determine time since last use
c. Determine concurrent use of other substances or prescriptions
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EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Consider using standardized Gossop, 1990 II Fair B
assessment of withdrawal Handelsman et al., 1987
symptoms. Pittman et al., 2007
Reoux et al., 2000
Sullivan et al., 1989
Wesson & Ling, 2003
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
BACKGROUND
Withdrawal management from a substance is defined as non-pharmacologic and/or pharmacologic
medical care with a goal of safely transitioning a patient from active use to sustained treatment for the
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patient’s substance use disorder. Withdrawal management is an essential initial gateway in preparing
many patients for additional treatment.
Pharmacologically supervised withdrawal is warranted only for alcohol, sedative-hypnotics, and
opioids; however, patients who use other illicit substances may find benefit in initiation of treatment
during their withdrawal period. For nicotine dependence, refer to Clinical Practice Guideline:
Treating Tobacco Use & Dependence: 2008 Update from the U.S. Department of Health and Human
Services at: http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf and the VA/DoD
Clinical Practice Guideline for the Management of Tobacco Use. Other substances do not require
pharmacological management for withdrawal.
It is important to distinguish patients with legitimate pain and/or anxiety disorders who develop only
physiological tolerance during long-term use of prescribed medications from those with markers of
prescription misuse.
RECOMMENDATIONS
1. Indications for withdrawal management from alcohol or sedative-hypnotics
• Patient with alcohol dependence with observed withdrawal symptoms
• CIWA-Ar score for at least mild withdrawal (>10)
• Patients with dependence on central nervous system depressants, due to the risks of untreated
withdrawal in severely dependent persons.
2. Relative contraindication for medically supervised withdrawal management from alcohol
• Patients with minimal withdrawal symptoms that are not accompanied by complicating co-
occurring disorders. Such patients may respond sufficiently to generalized support,
reassurance, and frequent monitoring.
3. Potential indications for medically supervised opioid withdrawal:
• Patient with physical dependence in the absence of clinical indications for ongoing treatment
(e.g., severe pain disorder)
• Patient with physical dependence accompanied by aberrant or non-adherent behavior (e.g.,
obtaining prescriptions from multiple providers, escalating doses without provider
consultation, or buying medications on the street)
• Agreement to provide naltrexone for treatment of opioid dependence
• Patient who does not request or want opioid agonist medical therapy but wants non-
pharmacologic treatment for opioid dependence.
4. Contraindication for opioid withdrawal management:
• Chronic severe opioid dependence. For such patients, first line therapy is methadone or
sublingual buprenorphine/naloxone maintenance treatment (See Module P - Addiction
Focused Pharmacotherapy)
• Two or more unsuccessful medically supervised withdrawal episodes within a 12-month
period. Such patients should be assessed for opioid agonist therapy.
5. Consider using a structured assessment tool to evaluate and track behaviors suggestive of
addiction, such as inappropriate medication use, and to increase the provider's confidence in
determinations of appropriate vs. inappropriate opioid use.
6. Evaluate opioid dependent patients for severe acute or chronic physical pain that may require
appropriate short-acting opioid agonist medication in addition to the medication needed to prevent
opioid withdrawal symptoms (see also VA/DoD Clinical Practice Guideline for Management of
Chronic Opioid Therapy at: http://www.healthquality.va.gov).
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EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Medically supervised withdrawal for dependence Mee-Lee et al., 2001 III Poor I
on central nervous system depressants.
2 General support and frequent monitoring for mild APA, 1995 III Poor I
withdrawal symptoms.
3 Consider structured assessment tool to evaluate and Wu et al., 2006 II Fair C
track behaviors suggestive of addiction.
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
BACKGROUND
Patients are more likely to complete an inpatient medically supervised withdrawal protocol; however,
long-term outcomes do not differ between inpatient and outpatient medically supervised withdrawal
programs. Relative advantages to consider include:
RECOMMENDATIONS
1. Consider the following indications for inpatient medically supervised withdrawal: [C]
a. Current symptoms of at least mild alcohol withdrawal (e.g., CIWA-Ar score ≥10)
b. History of delirium tremens or withdrawal seizures
c. Inability to tolerate oral medication
d. Imminent risk of harm to self or others
e. Recurrent unsuccessful attempts at ambulatory medically supervised withdrawal
f. Reasonable likelihood that the patient will not complete ambulatory medically
supervised withdrawal (e.g., due to homelessness)
g. Active psychosis or severe cognitive impairment
h. Chronic liver disease or cardiovascular disease, pregnancy, or lack of medical
support system.
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DISCUSSION
Compared to ambulatory settings, inpatient withdrawal management can often be done more rapidly
since access to alcohol and drugs is restricted. Withdrawal management performed while a patient is
in a clinically managed residential setting (e.g., some VA Substance Abuse Residential Rehabilitation
Treatment Programs [SARRTP]), is considered ambulatory.
This guideline endorses ASAM placement criteria for determining the appropriate level of care. To
ensure the patient’s safety during the withdrawal process in the least restrictive environment and
promote the long-term success for recovery, the following factors should be considered:
• Severity of current and past withdrawal symptoms based on standardized measures (e.g.,
CIWA-Ar, COWS
• Severity of co-occurring conditions
• The acceptance and potential to complete medically supervised withdrawal
• Recovery environment
• ASAM criteria (see Web site: http://www.asam.org).
ASAM (PPC-2R [2001]) recommends considering the following primary patient dimensions in making
a decision about appropriate level of care:
1. Acute intoxication and/or withdrawal potential, especially history of withdrawal seizures
2. Biomedical conditions and complications
3. Emotional/behavioral conditions and complications including:
o Psychiatric conditions
o Psychological or emotional/behavioral complications of known or unknown origin
o Poor impulse control
o Change in mental status
o Transient neuropsychiatric complications
4. Treatment acceptance/resistance
5. Relapse/continued use potential
6. Recovery/living environment.
EVIDENCE TABLE
Evidence Source QE Overall SR
Quality
1 Indications for inpatient medically ASAM, 2001 III Poor C
supervised withdrawal.
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
BACKGROUND
The objectives of withdrawal management from alcohol, sedative-hypnotics, or opioids in either
inpatient or ambulatory settings are to prevent the patient from experiencing adverse events and
prepare the patient for ongoing addiction treatment.
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RECOMMENDATIONS
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6. For managing mild to moderate alcohol withdrawal, carbamazepine and valproic acid can be used
as an effective supplement or alternative to benzodiazepines. They may be considered in patients
that cannot use benzodiazepines (e.g., abuse liability or allergy/adverse reactions). [B]
7. Other agents, such as beta-blockers, and clonidine, are generally not considered as appropriate
monotherapy for alcohol withdrawal, [D] but may be considered in conjunction with
benzodiazepines in certain patients. [C]
8. During and after medically supervised withdrawal, emphasis should be placed on engagement in
ongoing addiction treatment. [C]
9. Use of alcohol as an agent for medically supervised withdrawal is contraindicated. [D]
DISCUSSION
Considerable clinical experience and the largest accumulated body of data indicate that
benzodiazepines are the treatment of choice for pharmacotherapy for alcohol withdrawal on the basis
of such outcomes as the severity of the alcohol-withdrawal syndrome, occurrence of delirium, and
occurrence of seizures. One meta-analysis comparing benzodiazepines with placebo or with an active
control drug included 11 trials, representing a total of 1286 patients (Mayo-Smith, 1997). There was
more often a clinically significant reduction of symptoms within two days with benzodiazepines than
with placebo (common odds ratio, 3.28; 95 percent confidence interval, 1.30 to 8.28) (Mayo-Smith,
1997). In addition, benzodiazepines were more effective than placebo in reducing the incidence of
seizures (risk reduction, 7.7 seizures per 100 patients treated; P=0.003) and delirium (risk reduction,
4.9 cases of delirium per 100 patients treated=0.04) (Mayo-Smith, 1997). Individualizing therapy with
withdrawal scales results in administration of significantly less medication and shorter treatment
(Mayo-Smith, 1997).
A more recent meta-analysis included 57 trials with a total of 4051 subjects (Ntais et al., 2005). This
analysis was comprised of studies that compared benzodiazepines to placebo, to other
benzodiazepines, or to other medications. As in the other meta-analysis, benzodiazepines were clearly
superior to placebo in preventing withdrawal seizures (Ntais et al., 2005). This meta-analysis found
similar symptom reductions with benzodiazepines compared to other medications and similar capacity
of benzodiazepines to reduce seizures compared to anticonvulsants (Ntais et al., 2005).
Another recent meta-analysis focused on anticonvulsants, including carbamazepine and valproic acid,
for alcohol withdrawal and evaluated 48 studies, involving 3610 subjects (Polycarpou et al., 2005).
Given the heterogeneity across studies in methodology, differences between anticonvulsants and
placebo in achieving therapeutic success and preventing seizures favored anticonvulsants but did not
attain statistical significance (Polycarpou et al., 2005). Benzodiazepines remain the treatment of
choice for management of alcohol withdrawal.
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Beta-blockers and clonidine do reduce some signs and symptoms of alcohol withdrawal, but they do
not reduce seizures or delirium so they are not recommended as monotherapy (Mayo-Smith, 1997).
EVIDENCE TABLE
Evidence Source QE Overall Net SR
Quality Effect
1 Use symptom-triggered therapy APA, 1995 I Good Subst A
or gradual dose tapering over CSAT, 1995
several days for alcohol Hayashida et al., 1989
withdrawal management. Mayo-Smith, 1997
Saitz et al., 1994
2 Consider ambulatory medically Hayashida et al., 1989 I Good Subst A
supervised alcohol withdrawal, Mayo-Smith, 1997
when indicated.
3 Use benzodiazepines over non- Mayo-Smith, 1997 I Good Subst A
benzodiazepine sedative-
hypnotics for alcohol withdrawal
management.
4 For managing alcohol Mayo-Smith, 1997 I Fair Subst B
withdrawal, carbamazepine can Polycarpou et al., 2005
be used as an effective Reoux, 2001
alternative to benzodiazepines
for mild to moderate withdrawal.
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
RECOMMENDATIONS
1. Medically supervised opioid withdrawal is rarely effective as a long-term strategy for treatment of
opioid dependence because of high relapse rates. Opioid maintenance with
buprenorphine/naloxone or methadone is the definitive treatment of choice in most cases. [B]
2. If pursuing medically supervised opioid withdrawal, the preferred approaches are initial
stabilization and subsequent short or extended taper with opioid agonist therapy.
3. Set the length of the taper period based on the treatment setting and severity of the dependence.
4. Medically supervised withdrawal can usually be accomplished in 4 to 7 days in an inpatient
setting, to quickly achieve opioid abstinence prior to treatment in a drug-free setting, preferably
with initiaton of naltrexone.
5. Withdrawal using buprenorphine/naloxone:
a. Only physicians with a waiver from the US Department of Health and Human Services
can prescribe buprenorphine/naloxone
b. Initial stabilization is accomplished via induction with buprenorphine/naloxone just as it
would be for maintenance with this agent (See Table S-1). To reduce the risk of
precipitated withdrawal, the patient must be in sufficient opioid withdrawal to be
manifesting objective signs of withdrawal prior to starting buprenorphine/naloxone
usually at least 8 hours since the patient’s last use of heroin or other short-acting opioid
or at least 24 and preferably at least 48 hours have elapsed since the last use of
methadone or other long-acting opioid
c. Within 1-3 days, a daily dose of buprenorphine/naloxone should be achieved that
eliminates signs and symptoms of opioid withdrawal, suppresses opioid craving, and
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eliminates illicit opioid use. This dose could range from 2/0.5 mg per day to 16/4mg per
day and would rarely exceed that amount
d. Once stabilization has been achieved the dose can be rapidly tapered over 5-7 days.
There is little evidence that prolonging the taper leads to better results. (If the patient and
physician prefer a longer taper, there is also no evidence that a longer taper is harmful).
6. Withdrawal using methadone:
a. Withdrawal using methadone can only be performed in the context of a federally licensed
opioid treatment program where daily medication dispensing can occur. For patients not
engaged in methadone maintenance through an opioid treatment program, withdrawal
should be managed with buprenorphine
b. Initial stabilization is accomplished via induction with methadone just as it would be for
maintenance with this agent. Withdrawal signs do not have to be observed prior to
starting methadone, but with methadone there is risk of medication accumulation,
toxicity, and overdose. Initial dosing should be very conservative with careful daily
observation of the patient. Initial daily doses can range from 5 mg to a maximum of 30
mg
c. Within days to weeks, a daily dose of methadone should be achieved that eliminates signs
and symptoms of opioid withdrawal, suppresses opioid craving, and eliminates illicit
opioid use. This dose could range from 30 mg per day to doses as high as 120 mg per
day
d. Once stabilization has been achieved, the dose can be gradually tapered over a period of
weeks to months. Dose decreases of more than 5 -10 mg/day of methadone are generally
poorly tolerated. [C] In contrast to the evidence with buprenorphine/naloxone, with
methadone, longer taper periods should be used in the outpatient setting to minimize
patient discomfort and maximize chances of success
e. A period of two to three weeks is generally sufficient for short-term outpatient medically
supervised withdrawal in the most stable and motivated individual. The higher the
stabilization dose, the longer the taper is likely to take. The taper should proceed more
gradually as the dose becomes lower.
7. The 180-day stabilization/medically supervised withdrawal regimen should be considered to
facilitate work on patients’ early recovery problems, while stabilized on sublingual buprenorphine
or a relatively low dose (50-60 mg/day) of methadone. Stabilization is followed by short-term
medically supervised withdrawal from buprenorphine or methadone and transition to a drug-free
rehabilitation program.
8. Clonidine, an alpha-adrenergic agonist, can be considered as an adjunctive agent for symptom
relief during inpatient medically supervised opioid withdrawal; however, outpatient success is
much lower. If using clonidine, adjunctive medications for anxiety, restlessness, insomnia, muscle
aches, nausea, and diarrhea can also be prescribed.
DISCUSSION
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Alternative medically supervised withdrawal methods have been sought, due to concern that tapering
regimens using opioid agonists prolong the problem by prescribing an addictive medication. Many of
the symptoms of opioid withdrawal (e.g., diaphoresis, hyperactivity and irritability) appear to be
mediated by over-activity in the sympathetic nervous system. This resulted in trials that attempted to
depress the over-activity and ameliorate the withdrawal syndrome, using adrenergic agents, such as
clonidine and lofexidine, which are without abuse potential (Gold et al., 1978; Gold et al., 1980).
Clonidine, an alpha-adrenergic agonist with inhibitory action primarily at the locus ceruleus, is
effective in decreasing the signs and symptoms of opioid withdrawal in inpatient populations.
Inpatient studies reported an 80 to 90 percent success rate in detoxifying patients from methadone or
heroin, while outpatient studies have reported success rates as low as 30 to 35 percent (Cornish et al.,
1998).
The problems identified in outpatient clonidine medically supervised withdrawal include easier access
to heroin and other opioids, lethargy, insomnia, dizziness, and over-sedation. All of these problems are
more easily managed in the inpatient setting.
EVIDENCE TABLE
Evidence Source QE Overall Net SR
Quality Effect
1 Gradually decrease the dosage of CSAT, 1995 III Poor - C
the sedative-hypnotic or Smith & Wesson, 1994
substitute phenobarbital for the
addicting agent and taper
gradually.
2 During opioid medically Magura et al., 2001 II-2 Poor Mod B
supervised withdrawal, facilitate Simpson & Sells, 1990
engagement in comprehensive
long-term treatment.
3 Buprenorphine has demonstrated Gowing et al., 2006 I Good Subst A
greater efficacy in managing
withdrawal symptoms and in
completion of medically
supervised withdrawal treatment
in inpatient and outpatient
settings compared to alpha2
adrenergic agonists (e.g.,
clonidone).
4 Buprenorphine and methadone Amato et al.; 2005 I Good Subst A
appear to have equal efficacy in Gowing et al.; 2006
terms of completion of medically
supervised withdrawal treatment,
but withdrawal symptoms may
resolve more quickly with
buprenorphine.
QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A)
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8 mg 16 mg 24 mg 2 8
3 16
1 8 16 24
4 14
2 6 12 20
5 12
3 6 10 16
6 10
4 4 8 12
7 8
5 4 4 8
8 6
6 2 2 4
9 6
7 2 2 2
10 4
11 4
12 2
13 2
Table S- 2. Example Methadone Dosing Schedules for Withdrawal from Illicit Opioids
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BACKGROUND
Treatment of opioid withdrawal should focus on facilitating entrance into comprehensive long-term
treatment, as well as alleviating acute symptoms. Withdrawal management can be attempted with
patients who wish to detoxify from all opioids. There is a high relapse rate to heroin or other opioid use
unless stabilization is combined with psychosocial interventions. As such, withdrawal management is
not a stand-alone treatment modality.
RECOMMENDATIONS
1. Identify patients in need of additional withdrawal management or stabilization before proceeding
with further evaluation or treatment.
2. Medically supervised withdrawal is successful to the degree that the patient:
a. Is physiologically stable
b. Avoids hazardous medical consequences of withdrawal
c. Experiences minimal discomfort
d. Reports being treated with respect
e. Completes the medically supervised withdrawal protocol (e.g., no longer requires
medication for withdrawal symptom management).
BACKGROUND
Among patients for whom withdrawal management is unsuccessful or who decline engagement in
specialty care for rehabilitation, some patients may benefit from implementation of an ongoing care
management plan outside of specialty SUD care.
RECOMMENDATIONS
1. If medically supervised withdrawal is unsuccessful, or treatment engagement is not achieved,
consider one of the following:
a. A more intensive level of care for withdrawal management (e.g., inpatient)
b. Identify patients who can benefit from implementation of a care management plan, if
acceptable to the patient (see Module C, Annotation K).
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APPENDICES
Table of Contents
Page
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• Independent experts reviewed the draft and their feedback was integrated into the final draft
document.
This update of the SUD Guideline is the product of many months of diligent effort and consensus
building among knowledgeable individuals from the VA, DoD, academia, as well as guideline
facilitators from the private sector. An experienced moderator facilitated the multidisciplinary
Working Group. The list of participants is included in Appendix G.
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FORMULATION OF QUESTIONS
The Working Group developed researchable questions and associated key terms after orientation to the
scope of the guideline and to goals that had been identified by the Working Group. The questions
specified (adapted from the Evidence-Based Medicine toolbox, Center for Evidence-Based Medicine,
[http://www.cebm.net]):
• Population – Characteristics of the target patient population
• Intervention – Exposure, diagnostic, or prognosis
• Comparison – Intervention, exposure, or control used for comparison
• Outcome – Outcomes of interest.
These specifications served as the preliminary criteria for selecting studies. Literature searches were
conducted on all topics identified in the algorithm or recommendations of the original guidelines.
After reviewing the initial search for systematic reviews and meta-analyses, the Working Group
decided to focus the search for individual randomized controlled trials (RCT) on the following
questions:
Appendix A - Page 92
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
• In patients with a DSM diagnosis of Opioid Dependence who have failed prior outpatient
abstinence treatment, is there a difference in efficacy/effectiveness between maintenance
treatment with opioid agonist buprenorphine (buprenorphine or buprenorphine/naloxone)
compared to opioid agonist methadone in terms of consumption, relapse,
retention/engagement in the treatment program, and adverse events?
• In patients with a DSM diagnosis of Opioid dependence, is there a difference in
efficacy/effectiveness between initiating non-pharmacologic psychosocial interventions in
conjunction with pharmacotherapy compared to pharmacotherapy alone?
• In patients with a DSM diagnosis of Opioid dependence is there a difference in
efficacy/effectiveness between initiating buprenorphine within office-based outpatient
treatment compared to initiating methadone within an opioid agonist treatment program in
terms of consumption, relapse, retention/engagement in the treatment program, and adverse
events?
• In patients with a DSM diagnosis of Opioid dependence appropriate for withdrawal
management, is there a difference in efficacy/effectiveness between methadone or
buprenorphine or clonidine in terms of completion of the withdrawal process, safety,
engagement in subsequent treatment, and relapse?
Selection of Evidence
The evidence selection was designed to identify the best available evidence to address each key
question and ensure maximum coverage of studies at the top of the hierarchy of study types.
Published, peer-reviewed RCTs, as well as meta-analyses and systematic reviews that included
randomized controlled studies were considered to constitute the strongest level of evidence in support
of guideline recommendations. This decision was based on the judgment that RCTs provide the
clearest, scientifically sound basis for judging comparative efficacy. The Working Group made this
decision recognizing the limitations of RCTs, particularly considerations of generalizability with
respect to patient selection and treatment quality. When available, the search sought out critical
appraisals already performed by others that described explicit criteria for deciding what evidence was
selected and how it was determined to be valid. The sources that have already undergone rigorous
critical appraisal include Cochrane Reviews, Best Evidence, Technology Assessment, and AHRQ
systematic evidence reports.
In addition to Medline/PubMed, the following databases were searched: Database of Abstracts of
Reviews of Effectiveness (DARE) and Cochrane Central Register of Controlled Trials. For
Medline/PubMed searches, limits were set for language (English), and type of research (RCT,
systematic reviews and meta-analysis).
As a result of the literature reviews, articles were identified for possible inclusion. These articles
formed the basis for formulating the guideline recommendations. The following inclusion criteria
were used for studies:
• English language only of studies performed in United States, United Kingdom, Europe,
Australia, Japan, New Zealand
• Full articles only
• Study populations age limited to adults greater than 18 years; all races, ethnicities, cultural
groups
• Randomized controlled trials or prospective studies
• Published from 2002 to October 2007.
Appendix A - Page 93
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
Appendix A - Page 94
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
II-2 Well-designed cohort or case-control analytic study, preferably from more than one source
III Opinion of respected authorities, descriptive studies, case reports, and expert committees
More than a small relative impact on a frequent condition with a substantial burden of
suffering;
Substantial or
A large impact on an infrequent condition with a significant impact on the individual
patient level.
Appendix A - Page 95
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
Quality of Zero or
Substantial Moderate Small
Evidence Negative
Good A B C D
Fair B B C D
Poor I I I I
ALGORITHM FORMAT
The goal in developing the guideline for management of SUD was to incorporate the information into a
format which would maximally facilitate clinical decision-making. The use of the algorithm format
was chosen because of the evidence that such a format improves data collection, diagnostic and
therapeutic decision-making and changes patterns of resource use. However, few guidelines are
published in such a format.
Appendix A - Page 96
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
The algorithmic format allows the provider to follow a linear approach to critical information needed
at the major decision points in the clinical process, and includes:
• An ordered sequence of steps of care
• Recommended observations
• Decisions to be considered
• Actions to be taken
A clinical algorithm diagrams a guideline into a step-by-step decision tree. Standardized symbols are
used to display each step in the algorithm (Society for Medical Decision-Making Committee, 1992).
Arrows connect the numbered boxes indicating the order in which the steps should be followed.
A letter within a box of an algorithm refers the reader to the corresponding annotation. The
annotations elaborate on the recommendations and statements that are found within each box of the
algorithm. Included in the annotations are brief discussions that provide the underlying rationale and
specific evidence tables. Annotations indicate whether each recommendation is based on scientific
data or expert opinion. A complete bibliography is included in the guideline.
REFERENCES
Agency for Health Care Policy and Research (AHCPR). Manual for conduction systematic review.
Draft. August 1996. Prepared by Steven H. Woolf.
Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work
Group, Third US Preventive Services Task Force Current methods of the U.S. Preventive Services
Task Force: a review of the process. Am J Prev Med 2001 Apr;20(3 Suppl):21-35.
Society for Medical Decision-Making Committee (SMDMC). Proposal for clinical algorithm
standards, SMDMC on Standardization of Clinical Algorithms. Med Decis Making 1992 Apr-
Jun;12(2):149-54.
United States Preventive Service Task Force (USPSTF). Guide to clinical preventive services. 2nd
edition. Washington, DC: US Department of Health and Human Services, Office of Disease
Prevention and Health Promotion, 1996.
Woolf SH. Practice guidelines, a new reality in medicine II. Methods of developing guidelines. Arch
Intern Med 1992 May;152(5):946-52.
Appendix A - Page 97
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
Appendix B-1: Brief Alcohol Screening Questionnaires for Unhealthy Alcohol Use
2. On days in the past year when you drank alcohol how many drinks did you typically drink?
1 or 2 3 or 4 5 to 6 7 to 9 10 or more
3. How often do you have 6 or more drinks on an occasion in the past year?
Less than Daily or
Never Monthly Weekly
Monthly almost daily
Note: The AUDIT-C can be administered by interview or self-report.
Scoring AUDIT-C
Question 0 points 1 point 2 points 3 points 4 points
0 drinks and 1 or
2 2
3 or 4 5 to 6 7 to 9 10 or more
A positive screen is any report of drinking 5 or more (men) or 4 or more (women) drinks on an
occasion in the past year.
Appendix B - Page 98
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
REFERENCES
Overview:
Bradley KA, Kivlahan DR, Williams EC. Brief approaches to alcohol screening: practical alternatives
for primary care. J Gen Intern Med. Jul 2009;24(7):881-883.
AUDIT-C
Bush, K., D. R. Kivlahan, M. B. McDonell, S. D. Fihn & K. A. Bradley (1998) The AUDIT alcohol
consumption questions (AUDIT-C): an effective brief screening test for problem drinking.
Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification
Test. Arch Intern Med, 158, 1789-95.
Bradley KA, DeBenedetti AF, Volk RJ, Williams EC, Frank D, Kivlahan DR. AUDIT-C as a brief
screen for alcohol misuse in primary care. Alcohol Clin Exp Res. Jul 2007;31(7):1208-1217.
Bradley KA, Bush KR, Epler AJ, et al. Two brief alcohol-screening tests From the Alcohol Use
Disorders Identification Test (AUDIT): validation in a female Veterans Affairs patient population.
Arch Intern Med. Apr 14 2003;163(7):821-829.
SASQ
National Institute on Alcohol Abuse and Alcoholism, US Department of Health and Human Services
& National Institute of Health (2007) Helping Patients Who Drink Too Much: A Clinician’s Guide
(updated 2005 guide).
Smith, P. C., S. M. Schmidt, D. Allensworth-Davies & R. Saitz (2009) Primary Care Validation of a
Single-Question Alcohol Screening Test. J Gen Intern Med, 24, 783-788.
Appendix B - Page 99
VA/DoD Clinical Practice Guideline
For Management of Substance Use Disorders
Because alcohol use can affect your health and can interfere with certain medications and treatments, it is important that we
ask some questions about your use of alcohol in the last year. Your answers will remain confidential so please be honest.
Place an X in one box that best describes your answer to each question.
Questions 0 1 2 3 4
Two to four Two to Four or
1. How often do you have a drink Monthly or
Never times a three times more times
containing alcohol? less
month a week a week
2. How many drinks containing alcohol
do you have on a typical day when you 1 or 2 3 or 4 5 or 6 7 to 9 10 or more
are drinking?
Daily or
3. How often do you have six or more Less than
Never Monthly Weekly almost
drinks on one occasion? monthly
daily
4. How often during the last year have Daily or
Less than
you found that you were not able to Never Monthly Weekly almost
monthly
stop drinking once you had started? daily
5. How often during the last year have
Daily or
you failed to do what was normally Less than
Never Monthly Weekly almost
expected from you because of monthly
daily
drinking?
6. How often during the last year have
Daily or
you needed a first drink in the morning Less than
Never Monthly Weekly almost
to get yourself going after a heavy monthly
daily
drinking session?
7. How often during the last year have Daily or
Less than
you had a feeling of guilt or remorse Never Monthly Weekly almost
monthly
after drinking? daily
8. How often during the last year have
Daily or
you been unable to remember what Less than
Never Monthly Weekly almost
happened the night before because of monthly
daily
your drinking?
Yes, but Yes, during
9. Have you or someone else been
No not in the the last
injured as a result of your drinking?
last year year
10. Has a relative or friend, doctor or other
Yes, but Yes, during
healthcare worker been concerned
No not in the the last
about your drinking or suggested you
last year year
cut down?
Total
SCORING
NOTE: The AUDIT can be administered by interview or self-report.
2 1 or 2 3 or 4 5 to 6 7 to 9 10 or more
The minimum score (for non-drinkers) is 0 and the maximum possible score is 40.
The originally proposed WHO cut-off of 8 or more was based on the derivation sample (Saunders et.
al. 1993). In U.S. primary care studies and studies in VA outpatients, scores of 4 or more indicate a
positive screen for identification of risky drinking or alcohol use disorders; scores of 5 or more indicate
a positive screen for past-year DSM-IV alcohol use disorders (Volk et. al., 1997; Steinbauer et. al.,
1998; Bradley et. al., 1998; Bradley et. al., 2003).
REFERENCES
Bradley KA, DeBenedetti AF, Volk RJ, Williams EC, Frank D, Kivlahan DR. AUDIT-C as a brief
screen for alcohol misuse in primary care. Alcohol Clin Exp Res. Jul 2007;31(7):1208-1217.
Bradley KA, Bush KR, Epler AJ, et al. Two brief alcohol-screening tests From the Alcohol Use
Disorders Identification Test (AUDIT): validation in a female Veterans Affairs patient population.
Arch Intern Med. Apr 14 2003;163(7):821-829.
Bradley KA, Bush KR, McDonell MB, Malone T, Fihn SD. Screening for problem drinking:
comparison of CAGE and AUDIT. Ambulatory Care Quality Improvement Project (ACQUIP).
Alcohol Use Disorders Identification Test. J Gen Intern Med. Jun 1998;13(6):379-388.
Saunders JB, Aasland OG, Babor F, et al. Development of the alcohol use disorders screening test
(AUDIT). WHO collaborative project on early detection of persons with harmful alcohol
consumption, II. Addiction 1993;88:791-804.
Steinbauer JR, Cantor SB, Holzer CE, Volk JR. Ethnic and sex bias in primary care screening tests for
alcohol use disorders. Ann Intern Med. 1998;129:353-362.
Volk RJ, Cantor SB, Steinbauer JR, Cass AR. Item bias in the CAGE screening test for alcohol use
disorders. J Gen Intern Med. 1997;12:763-769.
Please check one response to each item that best describes how you have felt and behaved during your
whole life.
YES NO
1. Have you ever felt you should cut down on your drinking?
1 0
2. Have people annoyed you by criticizing your drinking?
1 0
3. Have you ever felt bad or guilty about your drinking?
1 0
4. Have you ever had a drink first thing in the morning to steady your
nerves or to get rid of a hangover (eye opener)? 1 0
SCORING
Item responses on the CAGE are scored 0 to 1, with a higher score an indication of alcohol problems.
A total score of 2 or greater is considered clinically significant.
REFERENCE
Bradley KA, Bush KR, McDonell MB, Malone T, Fihn SD. Screening for problem drinking:
comparison of CAGE and AUDIT. Ambulatory Care Quality Improvement Project (ACQUIP).
Alcohol Use Disorders Identification Test. J Gen Intern Med. Jun 1998;13(6):379-388.
Bradley KA, Kivlahan DR, Bush KR, McDonell MB, Fihn SD. Variations on the CAGE alcohol
screening questionnaire: strengths and limitations in VA general medical patients. Alcohol Clin
Exper Res. 2001;25(10):1472-1478.
Buchsbaum DG, Buchanan R, Centor R. Interpreting CAGE scores. Ann Intern Med.
1992;116(12):1032-1033.
How many times in the past year have you used an illegal drug or used a
prescription medication for non-medical reasons?
SCORING
A response of >1 was considered positive.
REFERENCE
PC Smith, D Allensworth-Davies, R Saitz. Single question screening for drug use in primary care.
Subst Abuse Volume 30/No. 1, 2009; page 88 (abstract; manuscript is under review).
Appendix B-5: WHO Alcohol, Smoking and Substance Involvement Screening Test
(ASSIST)
(Modified by NIDA)
Full screen available at http://www.nida.nih.gov/nidamed/screening/nmassist.pdf
SCORING
CIWA-Ar has 10 provider ratings. Interpret sum of total scores as follows:
• Minimal or absent withdrawal: ≤ 9
• Mild to moderate withdrawal: 10-19
• Severe withdrawal: > 20
REFERENCE
Sullivan JT, Sykora K, Schneiderman J, et al. Assessment of alcohol withdrawal: the revised Clinical
Institute Withdrawal Assessment for Alcohol scale (CIWA-AR). Brit J Addiction 1989;84:1353-7.
See web based training on use of CIWA-Ar for Prevention of Alcohol Withdrawal Syndrome at
www.detoxguideline.org
SCORING
COWS has 10 provider ratings. Interpret sum of total scores as follows:
• Mild withdrawal: 5-12
• Moderate withdrawal: 13-24
• Moderately severe withdrawal: 25-36
• Severe withdrawal: > 36
REFERENCE
Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs. 2003
Apr-Jun;35(2):253-9.
This is a standard set of questions about several areas of your life such as your health, alcohol and drug use
The questions generally ask about the past 30 days. Please consider each question and answer as accurately as possible.
1. In the past 30 days, would you say your physical health has been?
0- Excellent 1 - Very Good 2 - Good 3 - Fair 4 - Poor
2. In the past 30 days, how many nights did you have trouble falling asleep or staying asleep? ___ ___
3. In the past 30 days, how many days have you felt depressed, anxious, angry or very upset throughout most of the day?
___ ___
4. In the past 30 days, how many days did you drink ANY alcohol? (If 00, Skip to #6) ___ ___
5. How many days did you have at least (5-men, 4-women) drinks? [One drink is considered one shot of hard liquor (1.5 oz.) or
12 - ounce can/bottle of beer or 5 ounce glass of wine.] ___ ___
6. In the past 30 days, how many days did you use any illegal/street drugs or abuse any prescription medications?
(If 00, Skip to #8) ___ ___
7. What did you take? (Check all that apply)
__ 7a. Marijuana
__ 7b Sedatives/Tranquilizers (e.g., « benzos", Valium, Xanax, Ativan, Ambien, "barbs", Phenobarbital, downers, etc.)
__ 7c. Cocaine/Crack
__ 7d. Other Stimulants (e.g., amphetamine, methamphetamine, Dexedrine, Ritalin, Adderall, “speed”, "crystal meth", “ice”,
"crank", etc.)
__ 7e. Opiates (e.g., Heroin, Morphine, Dilaudid, Demerol, Oxcycontin, "oxcy", codeine (Tylenol 2,3,4), Percocet, Vicodin,
Fentanyl, etc.)
__ 7f. Other drugs (e.g., steroids, non-prescription sleep or diet pills, benadryl, ephedra, other over-the-counter/unknown meds,
etc)
8. In the past 30 days, how much were you bothered by cravings or urges to drink alcohol or use drugs?
0 - Not at all 1 - Slightly 2 - Moderately 3 - Considerably 4 - Extremely
9. How confident are you in your ability to be completely abstinent (clean) from alcohol and drugs in the next 30 days?
0 - Not at all 1 - Slightly 2 - Moderately 3 - Considerably 4 - Extremely
10. In the past 30 days, how many days did you attend self-help meetings like AA or NA to support your recovery? ___ ___
11. In the past 30 days, how many days were you in any situations or with any people that might put you at an increased risk
for using alcohol or drugs (i.e., around risky “people, places or things”)? ___ ___
12. Does your religion or spirituality help support your recovery?
0 - Not at all 1 - Slightly 2 - Moderately 3 - Considerably 4 - Extremely
13. In the past 30 days, how many days did you spend much of the time at work, school, or doing volunteer work? ___ ___
14. Do you have enough income (from legal sources) to pay for necessities such as housing, transportation, food and clothing
for yourself and your dependents?
0 - No 1 - Yes
15. In the past 30 days, how much have you been bothered by arguments or problems getting along with any family members
or friends?
0 - Not at all 1 - Slightly 2 - Moderately 3 - Considerably 4 - Extremely
16. In the past 30 days, how many days were you in contact or spend time with any family members or friends who are
supportive of your recovery? ___ ___
17. How satisfied are you with your progress toward achieving your recovery goals?
0 - Not at all 1 - Slightly 2 - Moderately 3 - Considerably 4 - Extremely
Interventions Alcohol Opioids Stimulants Cannabis Alcohol Opioids Stimulants Cannabis Comments
(alphabetical) /mixed /mixed
C-1 Behavioral +++ N/A +++ N/A +/- + ? N/A Effective for
Couples Therapy male or female
patients with
SUD and
partners;
improves
marital
satisfaction
C-2 Cognitive +++ N/A +++ ++ + +++ N/A ++
Behavioral Coping
Skills Training
C-1. Behavioral Couples Therapy (BCT)
DESCRIPTION
Most versions of behavioral couples therapy (BCT) are focused both on reducing alcohol or drug use
in the identified patient and on improving overall marital satisfaction for both partners. In BCT
sessions, the therapist arranges a daily Sobriety Contract in which the patient states his or her intent not
to drink or use drugs that day, and the partner expresses support for the patient’s efforts to stay
abstinent. The Sobriety Contract can also include urine drug screens for the patient, attendance at
other agreed-to counseling sessions, or 12-step meetings by the patient and partner. To improve
relationship functioning, BCT uses a series of behavioral assignments to increase positive feelings,
shared activities, and constructive communication because these relationship factors are conducive to
sobriety.
DISCUSSION
BCT has been evaluated in a number of randomized studies with alcohol or drug dependent individuals
and their partners. As a standalone treatment, it has consistently been found to improve drinking or
drug use outcomes and marital satisfaction to a greater degree than control conditions, which have
usually been individual or group standard addictions treatment (Epstein & McCrady, 1998; Fals-
Stewart et al., 1996, 2003; O’Farrell & Fals-Stewart, 2001; Shadish & Baldwin, 2005; Stanton &
Shadish, 1997). Studies have also shown that BCT is cost-effective, reduces violence, and improves
the psychosocial functioning of children in the family (Fals-Stewart et al., 1997, 2002; Kelley & Fals-
Stewart, 2002; O’Farrell et al., 1996a, 1996b, 1999). Although most studies have focused exclusively
on males with SUD and their female partners, several recent studies have also found that the
intervention is effective for female substance abusers and their male partners (Fals-Stewart et al.,
2006). However, it should be noted that BCT has been compared to other forms of couples therapy in
only a few studies which raises the question of whether it is in fact more effective than other conjoint
interventions (Walitzer & Dermen, 2004). In addition, the intervention has only been tested with
significant others who are not themselves substance abusers.
REFERENCES
Epstein E.E., & McCrady, B.S. (1998). Behavioral couples treatment of alcohol and drug use
disorders: Current status and innovations. Clinical Psychology Review. 1998;18:689-711.
Fals-Stewart, W., Birchler, G.R., et al. (2006). Learning sobriety together: A randomized trial
examining behavioral couples therapy with alcoholic female patients. Journal of Consulting and
Clinical Psychology, 74, 579-591.
Fals-Stewart, W. and T. J. O’Farrell (2003). Behavioral family counseling and naltrexone for male
opioid-dependent patients. J Consult Clin Psychol 71(3): 432-42.
Fals-Stewart, W., Birchler, G.R. & O’Farrell, T.J. (1996). Behavioral couples therapy for male
substance-abusing patients: Effects on relationship adjustment and drug-using behavior. Journal of
Consulting and Clinical Psychology, 64, 959-972.
Fals-Stewart, W., O’Farrell, T.J., & Birchler. G.R. (1997). Behavioral couples therapy for male
substance abusing patients: A cost outcomes analysis. Journal of Consulting and Clinical
Psychology, 65, 789-802.
Fals-Stewart, W., K. Klostermann, et al. (2005). Brief relationship therapy for alcoholism: a
randomized clinical trial examining clinical efficacy and cost-effectiveness. Psychol Addict
Behav 19(4): 363-71.
Fals-Stewart, W., T. B. Kashdan, et al. (2002). Behavioral couples therapy for drug-abusing patients:
effects on partner violence. J Subst Abuse Treat 22(2): 87-96
Hulse, G. K. (2003). Behavioural family andomized reduces drug use in opioid-dependent men.
Evid Based Ment Health 6(4): 123.
Kelley, M. L., & Fals-Stewart, W. (2002). Couples- versus individual-based therapy for alcohol and
drug abuse: effects on children’s psychosocial functioning. J Consult Clin Psychol 70(2): 417-27
O’Farrell T., & Fals-Stewart, W. (2001). Family-involved alcoholism treatment: An update. In:
Galanter M, editor. Recent Developments in Alcoholism, Volume 15: Services Research in the
Era of Managed Care. New York: Kluwer Academic/Plenum.
O’Farrell, T. J., Choquette, K. A., Cutter, H. S. G., Floyd, F. J., Bayog, R. D., Brown, E. D., Lowe, J.,
Chan, A., & Deneault, P. (1996a). Cost-benefit and cost-effectiveness analyses of behavioral
marital therapy as an addition to outpatient alcoholism treatment. Journal of Substance Abuse, 8,
145-166.
O’Farrell, T. J., Choquette, K. A., Cutter, H. S. G., Brown, E. D., Bayog, R., McCourt, W., Lowe, J.,
Chan, A., & Deneault, P. (1996b). Cost-benefit and cost-effectiveness analyses of behavioral
marital therapy with and without relapse prevention sessions for alcoholics and their spouses.
Behavior Therapy, 27, 7-24.
O’Farrell, T. J., Van Hutton, V., & Murphy, C. M. (1999). Domestic violence after alcoholism
treatment: A two-year longitudinal study. Journal of Studies on Alcohol, 60, 317-321.
Shadish WR, & Baldwin, S.A. (2005). Effects of behavioral marital therapy: A meta-analysis of
randomized controlled trials. Journal of Consulting and Clinical Psychology, 73:6-14.
Stanton MD, & Shadish, W.R. (1997). Outcome, attrition, and family-couples treatment for drug
abuse: A meta-analysis and review of the controlled, comparative studies. Psychological Bulletin,
122:170-91.
Walitzer, K. S., & Dermen, K.H. (2004). Alcohol-focused spouse involvement and behavioral couples
therapy: evaluation of enhancements to drinking reduction treatment for male problem drinkers. J
Consult Clin Psychol 72(6): 944-55.
DESCRIPTION
Cognitive-behavioral coping skills therapy consists of related treatment approaches for substance use
disorders that focus on teaching patients to modify both thinking and behavior related not only to
substance use, but to other areas of life functionally related to substance use. Patients learn to track
their thinking and activities and identify the affective and behavioral consequences of those thoughts
and activities. Patients then learn techniques to change thinking and behaviors that contribute to
substance use, and to strengthen coping skills, improve mood, interpersonal functioning and enhance
social support. Primary therapeutic techniques include education of the patient about the treatment
model, collaboration between the patient and therapist to choose goals, identifying unhelpful thoughts
and developing experiments to test the accuracy of such thoughts, guided discovery (facilitating the
patient in identifying alternative beliefs through the use of questions designed to explore current
beliefs), interpersonal skill building through communication and assertiveness training, behavioral
rehearsal, and role-play. In addition, treatment incorporates structured practice outside of session,
including scheduled activities, self-monitoring, thought recording and challenging, and interpersonal
skills practice.
DISCUSSION
Cognitive-behavioral coping skills therapy has been evaluated in a number of randomized studies and
has been empirically supported (Dutra et al., 2008; Wilbourne, 2005). Cognitive-behavioral coping
skills therapy has been shown to be effective with alcohol and drug dependent adults and adolescents
but not consistently superior to other interventions (Czruchry et al 2003; Ball et al 2007; Carroll et al;
Kaminer et al 2002).
REFERENCES
Ball, S. A., M. Todd, et al. (2007). Brief motivational enhancement and coping skills interventions for
heavy drinking. Addict Behav 32(6): 1105-18etc.
Carroll, K. M., C. J. Easton, et al. (2006). The use of contingency management and motivational/skills-
building therapy to treat young adults with marijuana dependence. J Consult Clin Psychol 74(5):
955-66.
Czuchry, M. and D. F. Dansereau (2003). Cognitive skills training: impact on drug abuse counseling
and readiness for treatment. Am J Drug Alcohol Abuse 29(1): 1-18
Dutra, L., Stathopoulou, G., Basden, S.L., Leyro, T.M., Powers, M.B., & Otto, M.W. (2008). A meta-
analytic review of psychosocial interventions for substance use disorders. Am J
Psychiatry;165(2):179-87.
Kaminer, Y., J. A. Burleson, et al. (2002). Cognitive-behavioral coping skills and psychoeducation
therapies for adolescent substance abuse. J Nerv Ment Dis 190(11): 737-45
Wilbourne PL An empirical basis for the treatment of alcohol problems. Dis Abstr Int 2005;66(5-
B):2844.
DESCRIPTION
Community Reinforcement Approach (CRA) is a comprehensive cognitive-behavioral intervention for
the treatment of substance abuse problems by focusing on environmental contingencies that impact and
influence the patient’s behavior. Developed in accordance with the belief that these environmental
contingencies play a crucial role in an individual’s addictive behavior and recovery, CRA utilizes
familial, social, recreational, and occupational events to support the individual in changing his or her
drinking/using behaviors and in creating a successful sobriety. The goal is to rearrange multiple
aspects of an individual’s life so that a sober lifestyle is more rewarding than one that is dominated by
alcohol and/or drugs. CRA integrates several treatment components, including building the patient’s
motivation to quit drinking/using, helping the patient initiate sobriety, analyzing the patient’s
drinking/using pattern, increasing positive reinforcement, learning new coping behaviors, and
involving significant others in the recovery process.
DISCUSSION
Numerous early clinical trials have found CRA to be effective in treating substance abuse and
dependence and in helping relatives recruit their loved ones into substance abuse treatment (Miller et
al., 1999). The trials were conducted in a variety of geographic regions, treatment settings (e.g.,
inpatient and outpatient), and individual and family therapy approaches. Furthermore, the patients in
those studies suffered from various substance-related problems and included homeless people as well
as people of different ethnic or cultural backgrounds. Consistently, CRA was more effective than the
traditional approaches with which it was compared or to which it had been added.
More recently, in the ongoing Mesa Grande project reviewing clinical trials of treatments for alcohol
use disorders (Miller & Wilbourne, 2002), CRA was rated as one of the psychosocial treatments
having the strongest evidence of efficacy. And in a study of 100 cocaine-dependent outpatients by
Higgins et al. (2003), patients treated with CRA plus vouchers were retained better in treatment, used
cocaine at a lower frequency during treatment (but not follow-up) and reported a lower frequency of
drinking to intoxication during treatment and follow-up compared with patients treated with vouchers
only. Patients treated with CRA plus vouchers also reported a higher frequency of days of paid
employment during treatment and the initial 6 months of follow-up, decreased depressive symptoms
during treatment only, and fewer hospitalizations and legal problems during follow-up.
REFERENCES
Higgins, S.T., Sigmon, S.C., Wong, C.J., Heil, S.H., Badger, G.J., Donham, R., Dantona, R.L., and
Anthony, S. (2003). Community reinforcement therapy for cocaine-dependent outpatients.
Archives of General Psychiatry. 60, 1043-1052.
Miller, W. R., & Wilbourne, P. L. (2002). Mesa Grande: A methodological analysis of clinical trials of
treatments for alcohol use disorders. Addiction, 97, 265-277.
Miller, W.R., Meyers, R.J., & Hiller-Sturmhofel, S. (1999). The Community reinforcement approach,
Alcohol Research & Health, 23, 116-121.
DESCRIPTION
Contingency Management (CM) approaches are based on behavioral principles of reinforcement that
reward specific behavioral goals related to recovery. Either monetary or nonmonetary rewards are
made contingent on objective evidence such as negative toxicology results (e.g., biological tests for
recent drug or alcohol use), treatment adherence, or progress toward treatment goals. The most
common form of contingencies provided to reinforce desired behaviors are vouchers with monetary
value that can be redeemed for goods and services, specific material prizes, or draws from a “fishbowl”
that contains cards which vary in their reinforcing value from simple praise to vouchers worth $1 to
$100. Schedules (fixed or intermittent) and magnitude of reinforcement have varied and have
implications for overall cost of clinical implementation.
DISCUSSION
Contingency Management can be effective in combination with pharmacotherapy (e.g., agonist
medications for opioid dependence) or in addition to cognitive behavioral therapy. These approaches
have shown consistent effectiveness with patients diagnosed with drug use disorders (Dutra et al.,
2008; Prendergast et al., 2006; Plebani-Lussier et al., 2006) for establishing a period of continuous
abstinence and early recovery. There has been limited evidence on patients with alcohol dependence.
In a meta-analytic review of psychosocial interventions for illicit SUDs, the highest effect size
estimates were obtained for CM approaches (Dutra et al., 2008), which also demonstrated the lowest
dropout rates. Prendergast et al. (2006) conducted a meta-analysis of treatment-control group studies
published since 1970 of CM with respect to drug use outcomes and found CM more effective in
treating opiate use (d* = 0.65) and cocaine use (d = 0.66), compared with tobacco (d = 0.31) or
multiple drugs (d = 0.42). However, for most interventions, the magnitude of the effect observed at the
end of treatment is not maintained in the months following treatment. Prendergast et al. (2006)
concludes that CM may be viewed as an adjunct to standard treatment, enhancing its effectiveness.
Whether CM can serve as a stand-alone treatment is not known (*d = standardized effect score).
In a meta-analysis of voucher-based reinforcement therapy (VBRT) for SUDs, VBRT significantly
improved treatment outcomes compared to control conditions (Plebani-Lussier et al., 2006). With the
exception of alcohol, which consisted of a single study, overall effect sizes for all targeted drugs
indicated that VBRT resulted in significantly better abstinence outcomes than control conditions. This
meta-analysis also offers support for the efficacy of VBRT for facilitating other therapeutic changes
(e.g. clinic attendance, medication compliance) in individuals with SUDs. Results suggest that
magnitude and immediacy of VBRT exert the strongest influence on effect size during treatment,
although the authors recommend future research in these areas.
REFERENCES
Dutra L, Stathopoulou G, Basden SL, Leyro TM, Powers MB, Otto MW. A meta-analytic review of
psychosocial interventions for substance use disorders. Am J Psychiatry. 2008 Feb;165(2):179-
87.
Plebani-Lussier J, Heil SH, Mongeon, JA, Badger GJ, Higgins ST. A meta-analysis of voucher-based
reinforcement therapy for substance use disorders. Addiction 2006;101:192-203.
Prendergast M, Podus D, Finney J, Greenwell L, Roll J. Contingency management for treatment of
substance use disorders: a meta-analysis. Addiction 2006;101:1546-60.
DESCRIPTION
Motivational enhancement therapy (MET) is a less intensive form of specialized psychosocial
intervention for patients with substance use disorders. MET uses principles of motivational
interviewing including an empathic, client-centered, but directive approach intended to heighten
awareness of ambivalence about change, promote commitment to change and enhance self-efficacy.
MET differs from MI in that it is a more structured intervention that is based to a greater degree on
systematic assessment with personalized feedback. The therapeutic style using motivational
interviewing elicits client reactions to assessment feedback, commitment to change and collaboration
on development of an individualized change plan. Involvement of a significant other is encouraged in
at least one of the MET sessions.
DISCUSSION
Motivational enhancement therapy (MET) (Miller et al., 1992), is more appropriate for patients with
alcohol dependence seeking specialty care from trained provides with demonstrated competence
(Martino et al., 2008; Miller et al., 2004). MI (Miller & Rollnick, 2002) has been effective as a stand-
alone intervention for non-treatment seeking patients with less severe disorders (Hettema et al., 2005;
Moyers et al., 2005).
MET has been evaluated in two major multi-center trials among patients with alcohol dependence. As
a stand-alone treatment, MET typically involves 3 to 4 sessions and yielded comparable benefits to
more intensive manualized interventions of 8 to 12 sessions (Project MATCH, 1997; UKATT
Research Team, 2001). MET also can improve outcomes for alcohol dependence as an adjunctive
intervention to treatment as usual (Ball et al., 2007) or can be integrated with CBT and 12-step
facilitation (Anton et al., 2006).
Both Project MATCH and the UKATT Study tested for differential effects of MET based on client
characteristics including gender and readiness for change, but found no significant matching effects
(UKATT); however Project MATCH found advantages of MET for patients with high levels of anger
at treatment entry (Project MATCH).
Among patients with cannabis dependence, two sessions of MET, did not reduce marijuana use over
15-month follow-up as much as a nine-session multicomponent intervention that also included
cognitive–behavioral therapy and case management (Babor et al. 2004). There is no incremental
effectiveness of MET on substance use outcomes when added to treatment as usual for patients with
other drug use disorders (Ball et al., 2007; Miller et al., 2003), including pregnant substance abusers
(Winhusen et al., 2007).
REFERENCES
Anton RF, O’Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM, et al. for the COMBINE
Study Research Group. Combined pharmacotherapies and behavioural Interventions for alcohol
dependence. The COMBINE study: a randomized controlled trial. JAMA 2006;293:2003–2017.
Ball SA, Martino S, Nich C, Frankforter TL, Van Horn D, Crits-Christoph P, Woody GE, Obert JL,
Farentinos C, Carroll KM; National Institute on Drug Abuse Clinical Trials Network. Site
matters: multisite randomized trial of motivational enhancement therapy in community drug abuse
clinics. J Consult Clin Psychol. 2007 Aug;75(4):556-67.
Babor TF. Brief Treatments for Cannabis Dependence: Findings from a Randomized Multisite Trial. J
Consult Clin Psychol. 2004;72:455-66.
Hettema J, Steele J, Miller WR. Motivational interviewing. Annual Review of Clinical Psychology.
2005;1:91-111.
Martino S, Ball SA, Nich C, Frankforter TL, Carroll KM. (2008). Community program therapist
adherence and competence in motivational enhancement therapy. Drug Alcohol Depend. Mar 5
[Epub ahead of print]
Miller, W. R., Yahne, C. E., Moyers, T. B., Martinez, J. & Pirritano, M. (2004). A randomized trial of
methods to help clinicians learn motivational interviewing. Journal of Consulting and Clinical
Psychology, 72, 1050–1062.
Miller WR, Yahne CE, Tonigan JS. Motivational interviewing in drug abuse services: A randomized
trial. J Consult Clin Psychol. 2003;71:754-63.
Miller, W. R., Zweben, A., DiClemente, C. & Rychtarik, R. (1992). Motivational Enhancement
Therapy: A Clinical Research Guide for Therapists Treating Individuals with Alcohol Abuse and
Dependence, Project MATCH Monograph series, (Vol. 2), DHHS pub. No. (ADM) 92–1894.
Washington DC: Department of Health and Human Services.
Moyers, T.B., Miller, W.R., & Hendrickson, S.M.L. (2005). How does motivational interviewing
work? Therapist interpersonal skill predicts client involvement within motivational interviewing
sessions. Journal of Consulting and Clinical Psychology, 73, 590-598.
Project MATCH research group. Matching alcoholism treatments to client heterogeneity: Project
MATCH Posttreatment drinking outcomes. J Stud Alcohol. 1997;58:7-29.
Raistrick D, Heather N, Godfrey C. Review of the effectiveness of treatment for alcohol problems.
London: National Treatment Agency for Substance Misuse, 2006.
Rohsenow DJ, Monti PM, Martin RA, Colby SM, Myers MG, Gulliver SB, et al. Motivational
enhancement and coping skills training for cocaine abusers: Effects on substance use outcomes.
Addiction. 2004;99:862-74.
UKATT Research Team. Effectiveness of treatment for alcohol problems: findings of the randomized
UK alcohol treatment trial (UKATT). BMJ 2005;311:541-4.
United Kingdom Alcohol Treatment Trial (UKATT): hypotheses, design and methods. Alcohol 2001
Jan-Feb;36(1):11-21.
Winhusen T, Kropp F, Babcock D, Hague D, Erickson SJ, Renz C, Rau L, Lewis D, Leimberger J,
Somoza E. Motivational enhancement therapy to improve treatment utilization and outcome in
pregnant substance users. J Subst Abuse Treat. 2007 Dec 14.
DESCRIPTION
Twelve Step Facilitation (TSF) therapy aims to increase the patient’s active involvement in Alcoholics
Anonymous (AA) or other twelve-step based mutual- (self-) help groups. This approach was
systematized in a manual for NIAAA’s Project MATCH and delivered as 12-sessions of individual
therapy in which the therapist actively encourages engagement in AA, and walks the patient through
the first four steps of the AA program. The therapist conveys the concept that addiction is a chronic,
progressive and potentially fatal illness for which the only successful strategy is abstinence achieved
one day at a time by following a 12-step program of recovery. Each therapy session is divided into
three parts. The first part reviews relevant events of the last week (including urges to use, drinking
behavior and recovery-oriented activities) and a homework assignment. The middle portion introduces
new material related to the 12-steps. The conclusion of the session includes a homework assignment
and development of a plan for recovery-oriented activities (meeting attendance, sponsor contact).
DISCUSSION
Twelve step facilitation (TSF) refers to formal psychotherapy administered by a professional that is
intended to foster the patient’s active participation in Alcoholics Anonymous or other 12 step-based
mutual-help programs. It assumes that alcoholism (or addiction) is a progressive illness that affects the
body, mind, and spirit for which the only effective strategy for recovery is abstinence from alcohol (or
other drugs). The individual can achieve complete abstinence one day at a time by following a 12-step
program of recovery as outlined in the “Big Book” of Alcoholics Anonymous (c1935, 1955, 1976,
2001) and through fellowship with others in recovery through the 12 traditions of Alcoholics
Anonymous.
Encouragement of participation in Alcoholics Anonymous (AA) and other 12 step-based mutual help
groups is widespread in community addiction treatment programs. Participation in twelve step-based
mutual help groups has been associated with improved outcome and reduction in healthcare costs in
numerous observational studies (Humphreys et al, 2004). In the relatively few randomized, controlled
clinical trials, TSF psychotherapy is associated with reduced drug and alcohol use compared to
baseline and (with one exception, Higgins et al, 1993) no significant differences in primary outcome
measures compared to other standardized addiction treatment psychotherapies. Two studies have
found significant advantages of TSF in secondary outcome measures such as treatment retention and
abstinence from alcohol.
Project MATCH (1997, 1998) is a multicenter, randomized, controlled clinical trial evaluating the
efficacy of individual psychotherapies for treatment of alcohol dependence. In Project MATCH, 1726
subjects were randomly assigned to TSF (12-sessions), Cognitive Behavioral Therapy (CBT, 12
sessions), or Motivation Enhancement Therapy (MET, 4 sessions). Patients in all three groups
improved in the primary outcome measures of addiction severity, with no significant differences
between the three groups. In addition, patients assigned to TSF were significantly more likely than
those assigned to CBT or MET to completely abstain from alcohol.
Project MATCH and 7 other randomized clinical trials of TSF for treatment of alcohol dependence
were reviewed by the Cochrane Collaboration (2006). Seven of these trials compared some form of
TSF to another active treatment and found no significant differences between them. One trial by Davis
and colleagues (2002) compared “standard” outpatient group and individual therapy emphasizing
participation in AA with minimal treatment (alcohol education videos) and found that both groups
significantly reduced their drinking over baseline, but the standard treatment group reduced average
daily alcohol consumption and increased abstinence significantly more than the minimal treatment
group.
Dutra and colleagues (2008) performed a meta-analytic review of psychosocial treatments for
substance use disorders other than alcohol. Of the 34 studies reviewed, three evaluated TSF. All three
compared TSF to another active treatment- Contingency Management (CM, Higgins et al, 1993),
Cognitive Behavioral Therapy (CBT, Carroll et al, 1998) or Dialectical Behavioral Therapy (DBT,
Linehan et al, 2002).
Higgins and colleagues (1993) compared a comprehensive behavioral therapy including community
reinforcement, relapse prevention training, employment assistance, and recreational therapy to
traditional drug counseling with weekly group and individual therapy emphasizing a 12-step approach
in 38 outpatient volunteers. Patients who were randomly assigned to comprehensive behavioral
therapy achieved better treatment retention (58% versus 11% at week 12) and significantly more
achieved 8 consecutive weeks of cocaine abstinence (68% versus 11%) as measured by urine drug
screen than the patients in 12-step based drug counseling.
Carroll and colleagues (1998) randomly assigned 122 patients with cocaine and alcohol dependence to
one of five treatment arms (TSF, CBT, TSF plus disulfiram, CBT plus disulfiram, or clinical
management plus disulfiram). Disulfiram treatment was significantly associated with treatment
retention and abstinence from cocaine and alcohol. TSF and CBT with disulfiram were both
significantly more effective than CM with disulfiram in increasing abstinence from cocaine with no
significant differences between the two.
Linehan and colleagues (2002) compared a 12-month course of dialectical behavioral therapy (DBT) to
comprehensive validation therapy with TSF (CVT+TSF) for treatment of heroin dependence in women
with borderline personality disorder receiving LAAM. Both treatments produced significant
reductions in positive urine drug screens for heroin (from >80% at baseline to 27% for DBT and 33%
for CVT +TSF at 16 months) with no significant differences between them. Patients assigned to TSF
were more likely to be retained in treatment (100% versus 64%) though those retained in DBT were
more likely to maintain reduction in positive urine drug screens during the last 4 months of treatment.
The preponderance of the evidence supports that AA participation is associated with improved
addiction outcome compared to baseline. TSF is more effective than minimal intervention and at least
as efficacious as CBT, MET and DBT for treatment of addiction. Though in one trial, TSF was
significantly less effective in reducing cocaine use than a comprehensive behavioral treatment
including contingency management, more research is needed to examine whether TSF may have more
enduring effects than other forms of psychosocial treatment. Detailed guidance for administering TSF
using the Project MATCH manual is available through the National Institute on Alcohol Abuse and
Alcoholism at http://pubs.niaaa.nih.gov/publications/match.htm.
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Executive Summary
Members are referred to Alcohol and Drug Abuse Prevention and Treatment (ADAPT) Program for
evaluation whenever substance use is suspected to be a contributing factor in any incident, e.g., DUI,
public intoxication, drunk and disorderly, family maltreatment/neglect, under-age drinking, medical
treatment, positive drug test, inappropriate behavior or substandard performance. Members can also
self-refer for an evaluation. If member is not diagnosed with alcohol abuse or dependence, a minimum
of 6 hours of awareness education is provided. If a diagnosis is warranted, a treatment plan is
established with the member, based on the severity of the condition, and an aftercare program is begun
following completion of treatment. Treatment is provided in the least restrictive environment possible,
according to severity. Members determined to be unresponsive to treatment will be processed for
administrative separation.
REFERENCE
A complete copy of DoDI 1010.6 is available on the following Web site: http://www.tricare.osd.mil.
For equivalent dose of commonly used Benzodiazepines and Barbiturates see : Weaver MF. Treatment of
sedative-hypnotic drug abuse in adults. In: UpToDate Online 16.3, Waltham, MA, 2009.
Joseph G. Liberto, MD
Director Mental Health Clinical Center
VA Maryland Healthcare System
10N Greene Street
Baltimore, MD 21201
Phone: (410) 605-7368
Email: joseph.liberto@va.gov
James E. McCrary, DO
Lt Col, USAF, MC
Air Force Medical Consultant
DoD Pharmacoeconomic Center
2450 Stanley Road, Suite 208
Fort Sam Houston, TX 78234-2789
Phone: (210) 295-1271
Email: James.mccrary@cen.amedd.army.mil
Edward L. McDaniel, MD
LTC, USA
Chief, Internal Medicine Service
Brooke Army Medical Center
3851 Roger Brooke Dr.
Fort Sam Houston, TX 78234-6200
Phone: (210) 916-0985
Email: Edward.mcdaniel@amedd.army.mil
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