Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction

198 Pages·2004·1.11 MB·English

Clinical Guidelines for the
Use of Buprenorphine
in the Treatment of
Opioid Addiction
A Treatment
Improvement
Protocol
TIP
40
BBBPPP
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Buprenorphine
Center for Substance Abuse Treatment Clinical Guide
www.samhsa.gov
BBBPPP
Buprenorphine
Clinical Guide
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0
Clinical Guidelines for the
Use of Buprenorphine
in the Treatment of
Opioid Addiction
Laura McNicholas, M.D., Ph.D.
Consensus Panel Chair
A Treatment
Improvement
Protocol
TIP
40
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment
1 Choke Cherry Road
Rockville, MD 20857
Acknowledgments described in this document are intended or
should be inferred. The guidelines in this
Numerous people contributed to the
document should not be considered
development of this TIP (see pp. ix, xi, and
substitutes for individualized client care and
appendix J). This publication was produced
treatment decisions.
by the American Institutes for Research®
(AIR) under the Center for Substance Abuse
Public Domain Notice
Treatment (CSAT) contract, task order
number 277-00-6401 under the Substance
All materials appearing in this volume except
Abuse and Mental Health Services
those taken directly from copyrighted sources
Administration (SAMHSA) contract, Number
are in the public domain and may be
277-99-6400, U.S. Department of Health and
reproduced or copied without permission from
Human Services (DHHS). CAPT Susanne SAMHSA/CSAT or the authors. Do not
Caviness, Ph.D., SR SURG Angel A.
reproduce or distribute this publication for a
González, M.D., and Raymond Hylton, Jr., fee without specific, written authorization
R.N., M.S.N., served as the CSAT from SAMHSA’s Office of Communications.
Government Project Officers. Anton C.
Bizzell, M.D., and Alan Trachtenberg, M.D.,
Electronic Access and Copies
M.P.H., served as the CSAT Medical Editors.
Christina Currier served as the CSAT TIPs of Publication
Task Leader. Elizabeth F. Howell, M.D.,
Copies may be obtained free of charge from
served as the Senior Medical Editor. Wayne
SAMHSA’s National Clearinghouse for Alcohol
Brandes, D.O., M.P.H., served as the AIR
and Drug Information (NCADI),
Medical Editor and Project Director. Janet
[phone] or [phone]; TDD (for
Carrese served as the AIR Deputy Project
the hearing impaired), [phone]; or
Director. Other AIR personnel included Susan
electronically through the following site:
Bratten, Senior Editor; Susan Keller, M.P.H.,
http://www.kap.samhsa.gov/products/
M.S., B.S.N., Quality Assurance Editor; and
manuals/index.htm.
Patricia Louthian, Document Production
Specialist. In addition, Center for Health
Policy Studies (CHPS) Consulting staff Roy Recommended Citation
Walker, M.B.A., Kimberly Stern, M.H.A.,
Center for Substance Abuse Treatment.
Elly Gilbert, M.S., R.N., C.H.E.S., and Ji
Clinical Guidelines for the Use of
Kim served as the original support team for
Buprenorphine in the Treatment of Opioid
the consensus and field review panels. Writers
Addiction. Treatment Improvement Protocol
were Margaret Boone, Ph.D.; Nancy J.
(TIP) Series 40. DHHS Publication No. (SMA)
Brown; Mary A. Moon; Deborah J. Schuman;
04-3939. Rockville, MD: Substance Abuse and
Josephine Thomas, M.F.A.; and Denise L.
Mental Health Services Administration, 2004.
Wright, Ph.D.
Originating Office
Disclaimer
Division of Pharmacologic Therapies, Center
The opinions expressed herein are the views of
for Substance Abuse Treatment, Substance
the consensus panel members and do not
Abuse and Mental Health Services
necessarily reflect the official position of
Administration, 1 Choke Cherry Road,
CSAT, SAMHSA, or DHHS. No official
Rockville, MD 20857.
support of or endorsement by CSAT,
SAMHSA or DHHS for these opinions or for DHHS Publication No. (SMA) 04-3939
particular instruments, software, or resources Printed 2004
iiii
Contents
What Is a TIP?.................................................................................................... vii
Consensus Panel...................................................................................................ix
Buprenorphine Expert Panel..................................................................................xi
Foreword .......................................................................................................... xiii
Executive Summary............................................................................................. xv
Chapter 1 Introduction ......................................................................................... 1
Practical Guidelines for Physicians ............................................................................1
Opioid Addiction Today in the United States.................................................................3
Current State of Opioid Addiction Treatment................................................................4
Current Pharmacotherapy Treatment Options for Opioid Addiction ..................................5
Buprenorphine: A New Treatment Option for Opioid Addiction ........................................6
Summary and Overview of the Guidelines ....................................................................9
Chapter 2 Pharmacology ......................................................................................11
Overview ............................................................................................................ 11
General Opioid Pharmacology................................................................................. 11
Pharmacology of Buprenorphine ............................................................................. 14
Buprenorphine Safety, Adverse Reactions, and Drug Interactions................................... 18
Effectiveness of Buprenorphine Treatment................................................................. 20
The Buprenorphine/Naloxone Combination................................................................ 23
Diversion and Misuse of Either Buprenorphine Alone or the
Buprenorphine/Naloxone Combination Product .......................................................... 23
Summary............................................................................................................ 24
Chapter 3 Patient Assessment................................................................................25
Overview ............................................................................................................ 25
Screening and Assessment of Opioid Use Disorders ...................................................... 25
Determining Appropriateness for Buprenorphine Treatment.......................................... 41
Chapter 4 Treatment Protocols .............................................................................49
Overview ............................................................................................................ 49
Maintenance Treatment With Buprenorphine ............................................................. 51
Opioid Detoxification With Buprenorphine ................................................................ 58
Patient Management ............................................................................................. 63
iii
Chapter 5 Special Populations ...............................................................................67
Overview .......................................................................................................... 67
Patients With Medical Comorbidities ...................................................................... 67
Pregnant Women and Neonates ............................................................................. 68
Adolescents/Young Adults..................................................................................... 71
Geriatric Patients............................................................................................... 73
Patients With Significant Psychiatric Comorbidity..................................................... 73
Polysubstance Abuse........................................................................................... 74
Patients With Pain ............................................................................................. 74
Patients Recently Discharged From Controlled Environments ...................................... 77
Healthcare Professionals Who Are Addicted to Opioids............................................... 78
Chapter 6 Policies and Procedures.........................................................................79
Overview .......................................................................................................... 79
The DATA 2000 Waiver ....................................................................................... 79
Preparing for Office-Based Opioid Treatment........................................................... 81
Confidentiality and Privacy.................................................................................. 83
Buprenorphine Use in OTPs ................................................................................. 84
Appendix A Bibliography.................................................................................... 87
Appendix B Assessment and Screening Instruments.................................................101
Appendix C DSM-IV-TR Material .........................................................................115
Appendix D Consent to Release of Information Under Title 42, Part 2, Code of
Federal Regulations ...........................................................................................119
Appendix E Clinical Toolbox: Chapter 3 Supplemental Information ...........................121
Appendix F Federation of State Medical Boards—Model Policy Guidelines
for Opioid Addiction Treatment in the Medical Office..............................................131
Appendix G Stages of Change ..............................................................................139
Appendix H Sample Treatment Agreement/Contract................................................147
Appendix I Glossary...........................................................................................149
Appendix J Field Reviewers.................................................................................153
Index ..............................................................................................................163
iv Contents
Figures
1–1 Dosage Forms of Buprenorphine Available in the United States...............................8
2–1 Conceptual Representation of Opioid Effect Versus Log Dose for
Opioid Full Agonists, Partial Agonists, and Antagonists....................................... 13
2–2 Bioavailability of Buprenorphine ................................................................... 16
2–3 Partial List of Medications Metabolized by Cytochrome P450 3A4 ......................... 21
3–1 Attributes of an Effective Addiction Treatment Provider..................................... 28
3–2 Targeted, Open-Ended Questions About Drug and Alcohol Use............................. 28
3–3 Quantifiable Interview Questions ................................................................... 29
3–4 Components of a Complete Substance Abuse Assessment History........................... 29
3–5 Examination Findings Suggestive of Addiction or Its Complications........................ 30
3–6 Signs of Opioid Intoxication and Overdose ....................................................... 31
3–7 Staging and Grading Systems of Opioid Withdrawal ........................................... 32
3–8 Mental Status Examination Checklist .............................................................. 32
3–9 Recommended Baseline Laboratory Evaluation of Patients
Who Are Addicted to Opioids........................................................................ 34
3–10 DSM-IV-TR Opioid Use Disorders (ICD-9 Code)................................................ 36
3–11 Selected Medical Disorders Related to Alcohol and Other Drug Use ....................... 38
3–12 Buprenorphine Treatment Checklist............................................................... 44
3–13 Conditions and Circumstances That May Preclude a Patient as a
Candidate for Office-Based Buprenorphine Treatment........................................ 45
4–1 Induction Days 1–2..................................................................................... 53
4–2 Induction Day 2 Forward............................................................................. 55
4–3 Stabilization Phase ..................................................................................... 57
4–4 Detoxification From Short-Acting Opioids........................................................ 60
4–5 Discontinuation of OAT Using Buprenorphine .................................................. 62
5–1 Clinical Features Distinguishing Opioid Use in Patients With Pain
Versus Patients Who Are Addicted to Opioids ................................................... 75
6–1 Policies, Procedures, and Items for Medical Practices To Establish Prior
to Initiating Office-Based Opioid Addiction Treatment ........................................ 83
6–2 Privacy and Confidentiality Issues in Addiction Treatment .................................. 84
Contents v
vi
What Is a TIP?
Treatment Improvement Protocols (TIPs) are best-practice guidelines
for the treatment of substance use disorders, provided as a service of
the Substance Abuse and Mental Health Services Administration’s
(SAMHSA’s) Center for Substance Abuse Treatment (CSAT). CSAT’s
Office of Evaluation, Scientific Analysis and Synthesis draws on the
experience and knowledge of clinical, research, and administrative
experts to produce the TIPs, which are distributed to a growing
number of facilities and individuals across the country. As alcoholism
and other substance use disorders are increasingly recognized as major
problems, the audience for the TIPs is expanding beyond public and
private substance use disorder treatment facilities.
After selecting a topic, CSAT invites staff from pertinent Federal
agencies and national organizations to a resource panel that recom-
mends specific areas of focus as well as resources that should be
considered in developing the content of the TIP. Then recommenda-
tions are communicated to a consensus panel composed of experts who
have been nominated by their peers. This panel participates in a series
of discussions; the information and recommendations on which they
reach consensus become the foundation of the TIP. The members of
each consensus panel represent substance use disorder treatment
programs, hospitals, community health centers, counseling programs,
criminal justice and child welfare agencies, and private practitioners.
A panel chair (or cochairs) ensures that the guidelines mirror the
results of the group’s collaboration.
A large and diverse group of experts reviews the draft document
closely. The Buprenorphine Expert Panel, a distinguished group of
substance abuse experts and professionals in such related fields as
primary care, mental health, and social services, worked with the
Consensus Panel Chair and the CSAT Division of Pharmacologic
Therapies to generate new and updated changes to the subject matter
for this TIP based on the field’s current needs for information and
guidance. Once the changes recommended by the field reviewers have
vii
been incorporated, the TIP is prepared for a new option for the treatment of opioid
publication in print and online. addiction. The goal of this TIP is to provide
information that physicians can use to make
The TIPs can be accessed via the Internet at practical and informed decisions about the use
http://www.kap.samhsa.gov/products/ of buprenorphine to treat opioid addiction.
manuals/index.htm. The use of electronic The Guidelines address a number of topic
media also means that the TIPs can be areas related to this goal, including the physi-
updated more easily so that they can continue ology and pharmacology of opioids, opioid
to provide the field with state-of-the-art addiction, and treatment with buprenorphine;
information. Although each TIP includes an the screening and assessment of opioid addic-
evidence base for the practices its panel tion problems; detailed protocols for opioid
recommends, CSAT recognizes that the field addiction treatment with buprenorphine;
of substance use disorder treatment is management of special populations; and
policies and procedures related to office-based
evolving continuously and that research
opioid addiction treatment under the para-
frequently lags behind the innovations
digm established by the Drug Addiction
pioneered by those in the field. A major goal
Treatment Act of 2000. This TIP represents
of each TIP is to convey “front line”
another step by CSAT toward its goal of
information quickly but responsibly. For this
bringing national leaders together to improve
reason, recommendations in the TIP are
substance use disorder treatment in the
attributed either to panelists’ clinical experi-
United States.
ence or to the appropriate literature. If there
is research to support a particular approach, Other TIPs may be ordered by contacting the
citations are provided. National Clearinghouse for Alcohol and Drug
Information (NCADI), [phone] or
This TIP, Clinical Guidelines for the Use of [phone]; TDD (for the hearing
Buprenorphine in the Treatment of Opioid impaired), [phone]. See http://
Addiction, provides consensus- and evidence- www.kap.samhsa.gov/products/manuals/
based guidance on the use of buprenorphine, index.htm.
viii What is a TIP?