Medication-Assisted Treatment For Opioid Addiction in Opioid Treatment Programs A Treatment Improvement Protocol TIP 43 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 5600 Fishers Lane Rockville, MD 20857 Acknowledgments Electronic Access and Printed Copies This publication was produced under the Knowledge Application Program (KAP), This publication may be ordered or contract numbers 270-99-7072 and 270-04 downloaded from SAMHSA’s Publications 7049, a Joint Venture of The CDM Group, Ordering Web page at http://store. Inc., and JBS International, Inc., for the samhsa.gov. Or, please call SAMHSA at Center for Substance Abuse Treatment 1-877-SAMHSA-7 (1-877-726-4727) (English (CSAT), Substance Abuse and Mental Health and Español). Services Administration (SAMHSA), U.S. Department of Health and Human Services Recommended Citation (HHS). Christina Currier served as the CSAT Government Project Officer, and Andrea Center for Substance Abuse Treatment. Kopstein, Ph.D., M.P.H., served as Deputy Medication-Assisted Treatment for Opioid Government Project Officer. Robert Lubran, Addiction in Opioid Treatment Programs. M.S., M.P.A., and Alan Trachtenberg, M.D., Treatment Improvement Protocol (TIP) Series served as CSAT technical experts. 43. HHS Publication No. (SMA) 12-4214. Rockville, MD: Substance Abuse and Mental Disclaimer Health Services Administration, 2005. The views, opinions, and content of this Originating Office publication are those of the consensus panel authors and do not necessarily reflect the Quality Improvement and Workforce views, opinions, or policies of SAMHSA or Development Branch, Division of Services HHS. No official support of or endorsement Improvement, Center for Substance Abuse by SAMHSA or HHS for these opinions or for Treatment, Substance Abuse and Mental particular instruments, software, or resources Health Services Administration, 5600 Fishers is intended or should be inferred. Lane, Rockville, MD 20857. Public Domain Notice HHS Publication No. (SMA) 12-4214 All materials appearing in this volume First Printed 2005 except those taken directly from copyrighted Revised 2006, 2008, 2010, 2011, 2012, 2014, sources are in the public domain and may and 2017. be reproduced or copied without permission from SAMHSA or the authors. Citation of the source is appreciated. However, this publication may not be reproduced or distributed for a fee without the specific, written authorization of the Office of Communications, SAMHSA, HHS. No substantive revisions have been made to this publication since its original printing. Contents What Is a TIP?............................................................................................................................................ix Consensus Panel........................................................................................................................................xi KAP Expert Panel and Federal Government Participants.......................................................... xiii Foreword .................................................................................................................................................... xv Executive Summary...............................................................................................................................xvii Chapter 1—Introduction ..........................................................................................................................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 2—History 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 3—Pharmacology 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 4—Initial 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 5—Clinical 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 6—Patient–Treatment Matching: Types of Services and Levels of Care .............................................................................................. 87 Steps in Patient–Treatment Matching ........................................................................................................88 Patients With Special Needs ........................................................................................................................91 Treatment Planning .....................................................................................................................................95 Chapter 7—Phases 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 8—Approaches 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 9—Drug 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 ..................................................................................151 Interpreting and Using Drug Test Results ...............................................................................................155 Reliability, Validity, and Accuracy of Drug Test Results ........................................................................157 iv Contents Chapter 10—Associated Medical Problems in Patients Who Are Opioid Addicted ............... 159 Integrated Versus Referral Services..........................................................................................................160 Routine Testing and Followup for Medical Problems ..............................................................................161 Acute, Life-Threatening Infections ............................................................................................................161 Infectious Diseases .....................................................................................................................................162 Patients With Disabilities ..........................................................................................................................171 Pain Management .......................................................................................................................................172 Hospitalization of Patients in MAT ...........................................................................................................176 General Medical Conditions and MAT ......................................................................................................176 Chapter 11—Treatment 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 12—Treatment 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 13—Medication-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 14—Administrative 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 A—Bibliography .................................................................................................................. 241 Appendix B—Abbreviations and Acronyms ..................................................................................... 279 Appendix C—Glossary ........................................................................................................................... 283 Appendix D—Ethical Considerations in MAT ................................................................................. 297 Fundamental Ethical Principles ................................................................................................................297 Ethics in Practice ........................................................................................................................................298 Ethics: Conclusion.......................................................................................................................................303 Appendix E—Resource Panel .............................................................................................................. 305 Appendix F—Field 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 Physicians’ 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 Simulation—Moderate 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: Patient–Treatment 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 10-1 Classification of TB ............................................................................................................................163 10-2 Hepatitis C Evaluation Flowchart ....................................................................................................167 10-3 Nonpharmacologic Approaches to Managing Chronic Nonmalignant Pain ...................................175 11-1 Reported Use of Other Substances by Patients Admitted to OTPs ...............................................180 Contents vii 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) are 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 (HHS). TIPs are best-practice guidelines for the treatment of substance use disorders. TIPs draw on the experience and knowledge of clinical, research, and administrative experts to evaluate the quality and appropriateness of various forms of treatment. TIPs are distributed to facilities and individuals across the country. Published TIPs can be accessed via the Internet at http://store.samhsa.gov. Although each TIP strives to include an evidence base for the practices it recommends, SAMHSA/CSAT recognizes that the field of substance abuse treatment is continually evolving, and research frequently lags behind the innovations pioneered in the field. A major goal of each TIP is to convey “front-line” information quickly but responsibly. If research supports a particular approach, citations are provided. This TIP, Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs, incorporates the many changes in medication- assisted treatment for opioid addiction (MAT) that have occurred over the most active decade of change since the inception of this treatment modality approximately 40 years ago. The TIP describes the nature and dimensions of opioid use disorders and their treatment in the United States, including basic principles of MAT and historical and regula tory developments. It presents consensus panel recommendations and evidence-based best practices for treatment of opioid addiction in opioid treatment programs (OTPs). It also examines related medical, psychiat ric, sociological, and substance use disorders and their treatment as part of a comprehensive maintenance treatment program. The TIP includes a discussion of the ethical considerations that arise in most OTPs, and it provides a useful summary of areas for emphasis in successfully adminis tering MAT in OTPs. ix
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