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Content Preview
Medication-Assisted Treatment
For Opioid Addiction in
Opioid Treatment Programs
A Treatment
Improvement
Protocol
TIP
43
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment
MEDICATION-
www.samhsa.gov
ASSISTED
TREATMENT

Medication-Assisted Treatment
For Opioid Addiction in
Opioid Treatment Programs
Steven L. Batki, M.D.
Consensus Panel Chair
Janice F. Kauffman, R.N., M.P.H., LADC, CAS
Consensus Panel Co-Chair
Ira Marion, M.A.
Consensus Panel Co-Chair
Mark W. Parrino, M.P.A.
Consensus Panel Co-Chair
George E. Woody, M.D.
Consensus Panel Co-Chair
A Treatment
Improvement
Protocol
TIP
43
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
The guidelines in this document should not be
considered substitutes for individualized client
Numerous people contributed to the
care and treatment decisions.
development of this Treatment Improvement
Protocol (see pp. xi and xiii as well as
Appendixes E and F). This publication was
Public Domain Notice
produced by Johnson, Bassin & Shaw, Inc.
All materials appearing in this volume except
(JBS), under the Knowledge Application
those taken directly from copyrighted sources
Program (KAP) contract numbers 270-99-
are in the public domain and may be reproduced
7072 and 270-04-7049 with the Substance
or copied without permission from SAMHSA/
Abuse and Mental Health Services
CSAT or the authors. Do not reproduce or
Administration (SAMHSA), U.S. Department
distribute this publication for a fee without
of Health and Human Services (DHHS).
specific, written authorization from SAMHSAís
Christina Currier served as the Center for
Office of Communications.
Substance Abuse Treatment (CSAT)
Government Project Officer, and Andrea
Kopstein, Ph.D., M.P.H., served as Deputy
Electronic Access and Copies
Government Project Officer. Robert Lubran,
of Publication
M.S., M.P.A., and Alan Trachtenberg, M.D.,
served as CSAT technical experts. Lynne
Copies may be obtained free of charge from
McArthur, M.A., A.M.L.S., served as
SAMHSAís National Clearinghouse for Alcohol
the JBS KAP Executive Project Co-Director.
and Drug Information (NCADI), (800) 729-6686
Barbara Fink, R.N., M.P.H., served as
or (301) 468-2600; TDD (for hearing impaired),
the JBS KAP Managing Project Co-Director.
(800) 487-4889; or electronically through the
Other JBS KAP personnel included Dennis
following Internet World Wide Web site:
Burke, M.S., M.A., Deputy Director for
www.ncadi.samhsa.gov.
Product Development; Wendy Caron,
Editorial Quality Assurance Manager;
Recommended Citation
Frances Nebesky, M.A., Quality Assurance
Editor; Leah Bogdan, Junior Editor; Emily
Center for Substance Abuse Treatment.
Tinkler, Junior Writer; and Pamela Frazier,
Medication-Assisted Treatment for Opioid
Document Production Specialist. Catalina
Addiction in Opioid Treatment Programs.
Vallejos Bartlett, M.A., Margaret Brooks,
Treatment Improvement Protocol (TIP) Series
J.D., Jonathan Max Gilbert, M.A., Randi
43. DHHS Publication No. (SMA) 05-4048.
Henderson, and Deborah J. Shuman
Rockville, MD: Substance Abuse and Mental
were writers.
Health Services Administration, 2005.
Disclaimer
Originating Office
The opinions expressed herein are the views
Practice Improvement Branch, Division of
of the consensus panel members and do not
Services Improvement, Center for Substance
necessarily reflect the official position of CSAT,
Abuse Treatment, Substance Abuse and Mental
SAMHSA, or DHHS. No official support of or
Health Services Administration, 1 Choke
endorsement by CSAT, SAMHSA, or DHHS
Cherry Road, Rockville, MD 20857.
for these opinions or for particular instruments,
software, or resources described in this
DHHS Publication No. (SMA) 05-4048
document is intended or should be inferred.
Printed 2005

Contents
What Is a TIP? ............................................................................................................ix
Consensus Panel ..........................................................................................................xi
KAP Expert Panel and Federal Government Participants ..................................................xiii
Foreword ...................................................................................................................xv
Executive Summary ...................................................................................................xvii
Chapter 1óIntroduction ...............................................................................................1
Purpose of This TIP .......................................................................................................1
Key Definitions..............................................................................................................2
Audience for This TIP.....................................................................................................2
A Decade of Change ........................................................................................................2
Remaining Challenges......................................................................................................6
The Future of MAT .......................................................................................................10
Chapter 2óHistory of Medication-Assisted Treatment for Opioid Addiction...........................11
Emergence of Opioid Addiction as a Significant Problem and the Roots of Controversy .................11
Origins of Opioid Maintenance Therapy .............................................................................17
Regulatory History........................................................................................................21
Chapter 3óPharmacology of Medications Used To Treat Opioid Addiction ...........................25
Pharmacology and Pharmacotherapy ................................................................................28
Dosage Forms ..............................................................................................................31
Efficacy......................................................................................................................32
Side Effects .................................................................................................................33
Interactions With Other Therapeutic Medications.................................................................36
Safety ........................................................................................................................42
Chapter 4óInitial Screening, Admission Procedures, and Assessment Techniques ..................43
Initial Screening ...........................................................................................................43
Admission Procedures and Initial Evaluation ......................................................................46
Medical Assessment .......................................................................................................49
Induction Assessment ....................................................................................................53
Comprehensive Assessment .............................................................................................53
Appendix 4-A. Example of Standard Consent to Opioid Maintenance Treatment ..........................61
iii

Chapter 5óClinical Pharmacotherapy ............................................................................63
Contraindications to Opioid Pharmacotherapy ....................................................................64
Stages of Pharmacotherapy.............................................................................................65
Medically Supervised Withdrawal ....................................................................................78
Take-Home Medications ................................................................................................81
Office-Based Opioid Therapy...........................................................................................85
Chapter 6óPatientñTreatment Matching:
Types of Services and Levels of Care ..........................................................................87
Steps in PatientñTreatment Matching ................................................................................88
Patients With Special Needs ............................................................................................91
Treatment Planning.......................................................................................................95
Chapter 7óPhases of Treatment..................................................................................101
Rationale for a Phased-Treatment Approach and Duration ...................................................101
Phases of MAT ...........................................................................................................102
Transition Between Treatment Phases in MAT....................................................................119
Readmission to the OTP ...............................................................................................120
Chapter 8óApproaches to Providing Comprehensive Care and
Maximizing Patient Retention .................................................................................121
Core Services .............................................................................................................121
Retaining Patients in MAT.............................................................................................122
Counseling and Case Management, Behavioral Treatments, and Psychotherapy .........................124
Benefits of Family Involvement.......................................................................................133
Integrative Approaches.................................................................................................135
Relapse Prevention......................................................................................................136
Referral to Social Services.............................................................................................138
Involuntary Discharge From MAT...................................................................................138
Patient Advocacy ........................................................................................................142
Chapter 9óDrug Testing as a Tool...............................................................................143
Purposes of Drug Testing in OTPs...................................................................................143
Benefits and Limitations of Drug Tests .............................................................................144
Drug-Testing Components and Methods ............................................................................148
Development of Written Procedures.................................................................................151
Other Considerations in Drug-Testing Procedures ...............................................................154
Interpreting and Using Drug Test Results..........................................................................155
Reliability, Validity, and Accuracy of Drug Test Results........................................................158
iv
Contents

Chapter 10óAssociated Medical Problems in Patients Who Are Opioid Addicted .................161
Integrated Versus Referral Services .................................................................................162
Routine Testing and Followup for Medical Problems............................................................163
Acute, Life-Threatening Infections ..................................................................................163
Infectious Diseases.......................................................................................................164
Patients With Disabilities ..............................................................................................173
Pain Management........................................................................................................174
Hospitalization of Patients in MAT ..................................................................................178
General Medical Conditions and MAT ..............................................................................178
Chapter 11óTreatment of Multiple Substance Use..........................................................179
Prevalence of Multiple Substance Use in MAT....................................................................180
Common Drug Combinations Used by Patients in MAT ........................................................181
Effects of Other Substance Use.......................................................................................182
Management of Multiple Substance Use in MAT..................................................................186
Inpatient Detoxification and Short-Term Stabilization..........................................................188
Chapter 12óTreatment of Co-Occurring Disorders ........................................................189
Prevalence of Co-Occurring Disorders..............................................................................190
Motivation for Treatment and Co-Occurring Disorders.........................................................191
Etiology of Co-Occurring Disorders .................................................................................191
Screening for Co-Occurring Disorders..............................................................................192
Making and Confirming a Psychiatric Diagnosis .................................................................194
Prognosis for Patients With Co-Occurring Disorders ...........................................................197
Treatment Issues .........................................................................................................199
Appendix 12-A. Internet Resources for Accessing Psychiatric Instruments ................................209
Chapter 13óMedication-Assisted Treatment for Opioid Addiction During Pregnancy ............211
Acceptance of Methadone Maintenance as the Standard of Care .............................................211
Diagnosing Opioid Addiction in Pregnant Patients ..............................................................212
Medical and Obstetrical Concerns and Complications ..........................................................212
Methadone Dosage and Management ................................................................................215
Postpartum Treatment of Mothers in MAT ........................................................................218
Breast-Feeding ...........................................................................................................218
Effects on Neonatal Outcome .........................................................................................218
Use of Buprenorphine During Pregnancy..........................................................................220
Importance of Integrated, Comprehensive Services .............................................................222
Nutrition Assessment, Counseling, and Assistance ...............................................................223
Contents
v

Chapter 14óAdministrative Considerations ...................................................................225
Staffing.....................................................................................................................225
Medication Diversion Control Plans.................................................................................230
The Community Effort .................................................................................................231
OTPs and National Community Education Initiatives ..........................................................236
Evaluating Program and Staff Performance.......................................................................238
Appendix AóBibliography..........................................................................................241
Appendix BóAbbreviations and Acronyms ....................................................................279
Appendix CóGlossary................................................................................................283
Appendix DóEthical Considerations in MAT..................................................................297
Fundamental Ethical Principles......................................................................................297
Ethics in Practice........................................................................................................298
Ethics: Conclusion.......................................................................................................303
Appendix EóResource Panel ......................................................................................305
Appendix FóField Reviewers ......................................................................................307
Index ......................................................................................................................317
CSAT TIPs and Publications Based on TIPs ...................................................................331

vi
Contents

Exhibits
1-1 NIDA Comprehensive Care-Related Principles of Effective Drug Addiction Treatment.............8
3-1 Pharmacotherapeutic Medications for Opioid Addiction Treatment ...................................26
3-2 Requirements for Physiciansí Waivers To Dispense or Prescribe Buprenorphine and
Buprenorphine-Naloxone to Patients Who Are Opioid Addicted .....................................27
3-3 Intrinsic Activity of Full Agonist (Methadone), Partial Agonist (Buprenorphine), and
Antagonist (Naloxone) Therapy ..............................................................................31
3-4 Possible Side Effects of Opioid Agonist and Partial Agonist Therapy..................................34
3-5 Reported Drug Interactions With Methadone ...............................................................37
3-6 Other Inducers and Inhibitors of CYP450 and CYP3A4 ..................................................40
4-1 Suicide Risk Factors...............................................................................................45
4-2 Recommended Responses to Indicators of Suicidality .....................................................45
4-3 Recommended Procedures for Identifying and Addressing Domestic Violence.......................57
5-1 Using Signs and Symptoms To Determine Optimal Methadone Levels .................................68
5-2 Induction SimulationóModerate to High Tolerance .......................................................69
5-3 Heroin Use in Preceding 30 Days
(407 Methadone-Maintained Patients by Current Methadone Dose) .................................73
5-4 Methadone Dose/Mean Plasma Levels .........................................................................74
5-5 Blood Plasma Levels Over 4 and 24 Hours With an Adequate and
Inadequate Methadone Dose ..................................................................................75
5-6 SMLs After Single and Split Methadone Dosing in a Fast Metabolizer .................................76
5-7 Types of Detoxification From Illicit Opioids .................................................................80
6-1 Case Study: PatientñTreatment Planning in MAT ..........................................................97
7-1 Acute Phase of MAT .............................................................................................104
7-2 Rehabilitative Phase of MAT...................................................................................109
7-3 Supportive-Care Phase of MAT ...............................................................................114
7-4 Medical Maintenance Phase of MAT .........................................................................116
7-5 Tapering Phase of MAT .........................................................................................118
8-1 Resource Materials for Psychoeducational, Skill-Building, and
Group Counseling Sessions..................................................................................127
8-2 Strategy for Contingency Management in MAT ............................................................129
8-3 Common Strategies for Psychotherapy in MAT............................................................131
8-4 Strategies for Psychoeducation in MAT .....................................................................133
8-5 Patient Goals in Building Relapse Prevention Skills......................................................137
9-1 Typical Testing and Confirmation Cutoff Concentrations and Detection Times for
Various Substances of Abuse ................................................................................145
9-2 Common Immunoassays.........................................................................................150
9-3 Sample OTP Guidelines for Monitoring Urine Drug Test Specimen Collection .....................151
9-4 Examples of Onsite Analytical Methods for Drug Tests ..................................................156
10-1 Classification of TB ..............................................................................................165
10-2 Hepatitis C Evaluation Flowchart ............................................................................169
Contents
vii

10-3 Nonpharmacologic Approaches to Managing Chronic Nonmalignant Pain ..........................177
11-1 Reported Use of Other Substances by Patients Admitted to OTPs ....................................180
11-2 Current Substance Use Disorders in Patients Dependent on Another Substance While
Addicted to Opioids and Admitted to OTPs,
With and Without Co-Occurring Disorders (N=716) ...................................................181
11-3 Drug Combinations and Common Reasons for Use .......................................................182
12-1 Common Co-Occurring Disorders in Patients Who Are Opioid Addicted............................191
12-2 DSM-IV-TR Classification of Diagnoses Associated With
Different Classes of Substances .............................................................................196
12-3 Mutual-Help Groups for People With Co-Occurring Disorders ........................................203
12-4 Topics for Psychoeducational Groups for People With Co-Occurring Disorders...................204
12-5 Interactions of Some Medications for Depression and Bipolar Disorder
With Methadone and Recommended Treatment Response in MAT .................................206
13-1 Common Medical Complications Among Pregnant Women Who Are Opioid Addicted............213
13-2 Laboratory Tests for Pregnant Women Who Are Opioid Addicted....................................214
13-3 Common Obstetrical Complications Among Women Addicted to Opioids ............................215
D-1 Case Example......................................................................................................299
D-2 AATOD Canon of Ethics ........................................................................................303
D-3 Ethical Codes of Selected Treatment-Oriented Organizations and Their Web Sites ...............304
viii
Contents

What Is a TIP?
Treatment Improvement Protocols (TIPs), developed by the Center for
Substance Abuse Treatment (CSAT), part of the Substance Abuse and
Mental Health Services Administration (SAMHSA), within the U.S.
Department of Health and Human Services (DHHS), are best-practice
guidelines for the treatment of substance use disorders. CSAT draws on
the experience and knowledge of clinical, research, and administrative
experts to produce the TIPs, which are distributed to facilities and indi-
viduals across the country. The audience for the TIPs is expanding
beyond public and private treatment facilities to include practitioners in
mental health, criminal justice, primary care, and other health care and
social service settings.
CSATís Knowledge Application Program (KAP) expert panel, a distin-
guished group of experts on substance use disorders and professionals in
such related fields as primary care, mental health, and social services,
works with the State Alcohol and Drug Abuse Directors to generate
topics for the TIPs. Topics are based on the fieldís current needs for
information and guidance.
After selecting a topic, CSAT invites staff from pertinent Federal
agencies and national organizations to be members of a resource panel
that recommends specific areas of focus as well as resources that should
be considered in developing the content for the TIP. These recommenda-
tions are communicated to a consensus panel composed of experts on the
topic who have been nominated by their peers. This consensus panel
participates in a series of discussions. The information and recommen-
dations on which they reach consensus form the foundation of the TIP.
The members of each consensus panel represent substance abuse treat-
ment programs, hospitals, community health centers, counseling pro-
grams, criminal justice and child welfare agencies, and private practi-
tioners. A panel chair (or co-chairs) ensures that the contents of the TIP
mirror the results of the groupís collaboration.
A large and diverse group of experts closely reviews the draft document.
Once the changes recommended by these field reviewers have been
incorporated, the TIP is prepared for publication, in print and on line.
TIPs can be accessed via the Internet at www.kap.samhsa.gov. The
ix

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