Medication-Assisted Treatment Opioid Treatment Programs

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Medication-Assisted TreatmentFor Opioid Addiction inOpioid Treatment ProgramsA TreatmentImprovementProtocolTIP43U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESSubstance Abuse and Mental Health Services AdministrationCenter for Substance Abuse Treatmentwww.samhsa.govMEDICATIONASSISTEDTREATMENT

Medication-Assisted TreatmentFor Opioid Addiction inOpioid Treatment ProgramsSteven L. Batki, M.D.Consensus Panel ChairJanice F. Kauffman, R.N., M.P.H., LADC, CASConsensus Panel Co-ChairIra Marion, M.A.Consensus Panel Co-ChairMark W. Parrino, M.P.A.Consensus Panel Co-ChairGeorge E. Woody, M.D.Consensus Panel Co-ChairA TreatmentImprovementProtocolTIP43U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESSubstance Abuse and Mental Health Services AdministrationCenter for Substance Abuse Treatment1 Choke Cherry RoadRockville, MD 20857

AcknowledgmentsNumerous people contributed to thedevelopment of this Treatment ImprovementProtocol (see pp. xi and xiii as well asAppendixes E and F). This publication wasproduced by Johnson, Bassin & Shaw, Inc.(JBS), under the Knowledge ApplicationProgram (KAP) contract numbers 270-997072 and 270-04-7049 with the SubstanceAbuse and Mental Health ServicesAdministration (SAMHSA), U.S. Departmentof Health and Human Services (DHHS).Christina Currier served as the Center forSubstance Abuse Treatment (CSAT)Government Project Officer, and AndreaKopstein, Ph.D., M.P.H., served as DeputyGovernment Project Officer. Robert Lubran,M.S., M.P.A., and Alan Trachtenberg, M.D.,served as CSAT technical experts. LynneMcArthur, M.A., A.M.L.S., served asthe JBS KAP Executive Project Co-Director.Barbara Fink, R.N., M.P.H., served asthe JBS KAP Managing Project Co-Director.Other JBS KAP personnel included DennisBurke, M.S., M.A., Deputy Director forProduct Development; Wendy Caron,Editorial Quality Assurance Manager;Frances Nebesky, M.A., Quality AssuranceEditor; Leah Bogdan, Junior Editor; EmilyTinkler, Junior Writer; and Pamela Frazier,Document Production Specialist. CatalinaVallejos Bartlett, M.A., Margaret Brooks,J.D., Jonathan Max Gilbert, M.A., RandiHenderson, and Deborah J. Shumanwere writers.The guidelines in this document should not beconsidered substitutes for individualized clientcare and treatment decisions.Public Domain NoticeAll materials appearing in this volume exceptthose taken directly from copyrighted sourcesare in the public domain and may be reproducedor copied without permission from SAMHSA/CSAT or the authors. Do not reproduce ordistribute this publication for a fee withoutspecific, written authorization from SAMHSAísOffice of Communications.Electronic Access and Copiesof PublicationCopies may be obtained free of charge fromSAMHSAís National Clearinghouse for Alcoholand Drug Information (NCADI), (800) 729-6686or (301) 468-2600; TDD (for hearing impaired),(800) 487-4889; or electronically through thefollowing Internet World Wide Web site:www.ncadi.samhsa.gov.Recommended CitationCenter for Substance Abuse Treatment.Medication-Assisted Treatment for OpioidAddiction in Opioid Treatment Programs.Treatment Improvement Protocol (TIP) Series43. DHHS Publication No. (SMA) 05-4048.Rockville, MD: Substance Abuse and MentalHealth Services Administration, 2005.DisclaimerOriginating OfficeThe opinions expressed herein are the viewsof the consensus panel members and do notnecessarily reflect the official position of CSAT,SAMHSA, or DHHS. No official support of orendorsement by CSAT, SAMHSA, or DHHSfor these opinions or for particular instruments,software, or resources described in thisdocument is intended or should be inferred.Practice Improvement Branch, Division ofServices Improvement, Center for SubstanceAbuse Treatment, Substance Abuse and MentalHealth Services Administration, 1 ChokeCherry Road, Rockville, MD 20857.DHHS Publication No. (SMA) 05-4048Printed 2005

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

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

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

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

Exhibits1-1 NIDA Comprehensive Care-Related Principles of Effective Drug Addiction Treatment.83-1 Pharmacotherapeutic Medications for Opioid Addiction Treatment .263-2 Requirements for Physiciansí Waivers To Dispense or Prescribe Buprenorphine andBuprenorphine-Naloxone to Patients Who Are Opioid Addicted .273-3 Intrinsic Activity of Full Agonist (Methadone), Partial Agonist (Buprenorphine), andAntagonist (Naloxone) Therapy .313-4 Possible Side Effects of Opioid Agonist and Partial Agonist Therapy.343-5 Reported Drug Interactions With Methadone .373-6 Other Inducers and Inhibitors of CYP450 and CYP3A4 .404-1 Suicide Risk Factors.454-2 Recommended Responses to Indicators of Suicidality .454-3 Recommended Procedures for Identifying and Addressing Domestic Violence.575-1 Using Signs and Symptoms To Determine Optimal Methadone Levels .685-2 Induction SimulationóModerate to High Tolerance .695-3 Heroin Use in Preceding 30 Days(407 Methadone-Maintained Patients by Current Methadone Dose) .735-4 Methadone Dose/Mean Plasma Levels .745-5 Blood Plasma Levels Over 4 and 24 Hours With an Adequate andInadequate Methadone Dose .755-6 SMLs After Single and Split Methadone Dosing in a Fast Metabolizer .765-7 Types of Detoxification From Illicit Opioids .806-1 Case Study: PatientñTreatment Planning in MAT .977-1 Acute Phase of MAT .1047-2 Rehabilitative Phase of MAT.1097-3 Supportive-Care Phase of MAT .1147-

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 Medication-Assisted Treatment For Opioid Addiction in Opioid Treatment Programs

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