Methadone Maintenance in the Treatment of Heroin Addiction

1. Methadone Maintenance in the Treatment of Heroin Addiction Prop 36 CLAIM Meeting - Oct 2003 Joan E. Zweben, Ph.D. Executive Director: 14th Street Clinic and EBCRP Clinical Professor of Psychiatry; University of California, San Francisco

2. Questions & Issues How important is methadone in treating heroin addiction? What is the rationale? What is the data? How do we decide when/if it can be discontinued? What is included in the psychosocial component of treatment?

3. Natural History of Heroin Addiction: A 33-Year Follow-up (1) 581 male heroin addicts, admitted to Calif Civil Addicts Program, 1962-1964 CAP: compulsory drug tx for heroin-dependent criminal offenders 284 dead; 242 interviewed High rates of disability, hepatitis, excessive drinking, cigarette smoking, marijuana use, other drug-related problems (Hser et al, 2001)

4. Narcotics Addicts: A 33-Year Follow-up (2) Between 1985-1986 to 1996-1997: Dead: 49% Abstinent: 20%-22% Incarcerated: 4%-7% Methadone maintenance: 2%-6% Occasional use: 2%-3% Lost to follow-up: 12 (Hser et al, 2001)

5. Opiate Dependency:Hidden Populations Subscribers of Private Insurance Plan: Empire Blue Cross/Blue Shield, NYC estimated from opiate dependency diagnosis on admission & AIDS cases insured 141,000 opiate users between 1982-1992 85,000 among current subscribers (1992) (Eisenhandler & Drucker, 1993) REFERENCES; Eisenhandler, J. & Drucker, E. (1993). Opiate dependency among the subscribers of a New York area private insurance plan. Journal of the American Medical Association, 269 (22), 2890-2891.REFERENCES; Eisenhandler, J. & Drucker, E. (1993). Opiate dependency among the subscribers of a New York area private insurance plan. Journal of the American Medical Association, 269 (22), 2890-2891.

6. Treatment Outcome Data: Methadone 8-10 fold reduction in death rate Reduction of drug use Reduction of criminal activity Engagement in socially productive roles; improved family and social function Increased employment Improved physical and mental health Reduced spread of HIV Excellent retention

7. DEATH RATES IN TREATED AND UNTREATED HEROIN ADDICTS

8. Impact of MMT on IV Drug Use for 388 Male MMT Patients in 6 Programs

9. Relapse to IV drug use after MMT105 male patients who left treatment

10. Crime among 491 patients before and during MMT at 6 programs

12. HIV CONVERSION IN TREATMENT

13. OPIOID MAINTENANCETHERAPY

14. The Addiction Process:Barriers to Understanding INFLUENCE OF THE STIGMA: difficulty understanding the complexity of the disorder treatment is denied treatment is diminished treatment is discouraged treatment is conditional Refusal to admit to treatment Disgust and distrust lead to withholding meds, services Treatment offered in begrudging manner; provider is an adversary. Fosters dropout. Pt offered services or granted rights only if she will withdraw from MMT. As abstinence syndrome develops, pt becomes agitated and acts out, confirming negative stereotypes Refusal to admit to treatment Disgust and distrust lead to withholding meds, services Treatment offered in begrudging manner; provider is an adversary. Fosters dropout. Pt offered services or granted rights only if she will withdraw from MMT. As abstinence syndrome develops, pt becomes agitated and acts out, confirming negative stereotypes

15. �I Don�t Believe in Methadone�

16. Methadone is a medication,not a religion J. Thomas Payte, MD Founding Chair, Methadone Treatment Committee, ASAM

17. Overview:Opioid Maintenance Therapy Methadone (MMT) & levoacetylmethadol (LAAM), buprenorphine (soon) most highly regulated history rationale for replacement therapy political influences diversion

18. OMT, Continued Strong empirical support for safety and efficacy (30 years of data) valuable tool in reducing spread of HIV makes the pt accessible to interventions for other problems hidden populations of heroin users medical maintenance and office-based practice

19. What is Abstinence? Medication is compatible with 12-step participation if appropriately prescribed by physician knowledgeable about addiction Pt on methadone is abstinent if not using illicit drugs and using legal ones as prescribed It�s just another medication. Meds are a tool, not a solution

20. Dole: Receptor System Dysfunction Endogenous ligand-narcotic receptor system is defective; hence high relapse rate Stabilize blood level at 150-600 ng/mL This normalizes neurological and endocrine functioning This treatment is corrective but not curative Future research: identify the specific defect and repair it (Dole, JAMA 1988)

21. Genetic Factors Recent studies show distinct genetic vulnerability to heroin and other opiates: heroin had larger genetic influences unique to itself than marijuana, sedatives, stimulants, psychedelics (Tsuang et all; Merikangas et al; ARCHIVES 1998) Alcoholism and drug disorders appear to be independent Genetic factors impact the transition from drug use to abuse/dependence, not use itself

22. Diversion of Medication political hot button key issue in formulating original regs IOM report: cannot document significant public health or safety problem confusion about DAWN data difficulty of determining cause of death (Rettig 1995) REFERNCES: Rettig, R.A. & Yarmolinsky, A. (Eds.)(1995). Federal Regulation of Methadone Treatment. Division of Behavioral Sciences and Mental Disorders; Institute of Medicine. Washington D.C.: National Academy Press.REFERNCES: Rettig, R.A. & Yarmolinsky, A. (Eds.)(1995). Federal Regulation of Methadone Treatment. Division of Behavioral Sciences and Mental Disorders; Institute of Medicine. Washington D.C.: National Academy Press.

23. Reasons for Diversion selling take-homes to buy illicit drugs need to supplement income share with or sell to addicted friend/mate unwilling or unable to enter treatment low dose policies of some programs IOM conclusion: risks of diverted methadone do not outweigh benefits of making MMT more available (Rettig 1995)

24. PHARMACOTHERAPY

25. Methadone vs Heroin Can be taken by mouth Slow onset of action No continuing increase in tolerance levels after optimal dose is reached; relatively constant dose over time Pt on stable dose rarely experiences euphoric or sedating effects; is able to perceive pain and have emotional reactions; can perform; can perform daily tasks normally and safely

26. Methadone vs Heroin (2) Long acting; prevents withdrawal for 24-36 hours (4x-6x as long as heroin), permitting once-a day-dosing At sufficient dosage, blocks euphoric effect of normal street doses of heroin Medically safe when used on long-term basis (10 years or more) (Physician�s Guide: Opioid Agonist Medical Maintenance Treatment; CSAT 2000)

29. PROFILE FOR POTENTIAL PSYCHOTHERAPEUTIC AGENT Effective after oral administration Long biological half-life (>24 hours) Minimal side effects during chronic administration Safe, no true toxic or serious adverse effects Efficacious for a substantial % of persons with the disorder (> 15-20%)

31. �Not Holding� Strategies Cognitive, Behavioral Interventions Increased contact, counseling, therapy Alter urinary pH? Is patient fixing? - Raise dose Split Dose?

32. Rapid Metabolizer - High Single and Split Dose Simulation

33. TAPERING how many remain abstinent? tapering readiness tapering strategies clonidine handling relapse

34. Buprenorphine (1) 1970�s - partial opioid agonist useful in opioid dependence treatment 1990�s - clinical trials long duration of action; smooth onset low physical dependence mild withdrawal syndrome good name on the street

35. Buprenorphine (2) DATA 2000 permitted use in MD office FDA approved Subutex and Suboxone in 2002 Physicians must meet training requirements: certified in addiction medicine, participated in clinical trials, or took 8 hour course by specified organizations

36. Buprenorphine (3) SUBUTEX & SUBOXONE Sublingual tablets Suboxone has naloxone added to discourage needle use Partial agonist: ceiling effect Expensive: $300/month at average dose Not interchangeable with methadone

37. Buprenorphine (4) Poor oral bioavailability Sublingual administration requires longer observation Abuse documented in Europe, Australia, and New Zealand How much training should be required for physicians to use it?

38. Naltrexone antagonist; how it works who does it work for? accelerated withdrawal protocols Dole�s critique utility with alcoholics

39. Methadone in Pregnancy Comprehensive MMT treatment with prenatal care improves neonatal outcome Withdrawal is rarely appropriate during pregnancy Methadone is not teratogenic; children have been followed into adulthood Appropriate dosing is very important Breast feeding OK if no other drug use

40. Opioids and Chronic Pain Opioid tolerance & physical dependence DO NOT equal opioid addiction Loss of Control Indices: Continued use despite adverse consequences Illicit or inappropriate drug seeking behavior In response to craving or drug hunger In the absence of pain or withdrawal

41. Pseudo Addiction- in chronic pain patient Inadequate Treatment of Pain �Apparent� Drug Seeking Behavior Effort to achieve adequate analgesia Early refill, doctor shopping, etc. Manipulation seen as �addictive behavior� May be seen as non-compliance �Cured� by adequate treatment of pain

42. Chronic Pain Disorder Opioid Tolerance Opioid Physical Dependence Absence of illicit or inappropriate drug seeking behavior No drug hunger in absence of pain No loss of control No �doctor shopping� Little tendency to escalate dose over time

43. PSYCHOSOCIAL TREATMENT ISSUES

44. Population Characteristics Heterogeneity Readiness for recovery; motivation Psychiatric comorbidity Medical comorbidity

45. Program Characteristics Medical component: assessment, dosing, client interactions Individual counseling Group counseling Case management Staff training (ongoing)

46. What is Abstinence? Medication is compatible with 12-step participation if appropriately prescribed by physician knowledgeable about addiction Pt on methadone is abstinent if not using illicit drugs and using legal ones as prescribed It�s just another medication. Meds are a tool, not a solution

47. Cognitive-Behavioral Therapy Lends itself to controlled studies; strong support for its effectiveness Especially useful to help establish abstinence, teach early recovery and relapse prevention skills Emphasizes changing behavior and managing symptoms

48. Cognitive Behavioral Strategies (CBT) MATRIX MODEL - Organizing Principles Create explicit structure and expectations Establish positive, collaborative relationship Teach information and CBT concepts Positively reinforce behavior change Provide corrective feedback when necessary Encourage self-help participation

49. CBT: MATRIX MODEL Structure is essential: time scheduling, self-help meetings, exercise, work, treatment activities Identify external and internal triggers and make a plan Tools for managing cravings: thought stopping, visual imagery, change environment/behavior TIP #33 has description, patient worksheets (Rawson 1999)

50. Clinical Issues

51. Is Psychotherapy Useful? Philadelphia group study, begun 1977 global psychiatric status ratings elements of drug counseling models of psychotherapy utilized benefits to low severity patients benefits to high severity patients REFERENCES: Woody, G.; Luborsky, L.; McLellan, A.T.; O�Brien, C.P (1986). Psychotherapy as an adjunct to methadone treatment. In: Meyer, R. (Ed.), Psychopathology and Addictive Disorders, 169-195. New York: Guilford Press.REFERENCES: Woody, G.; Luborsky, L.; McLellan, A.T.; O�Brien, C.P (1986). Psychotherapy as an adjunct to methadone treatment. In: Meyer, R. (Ed.), Psychopathology and Addictive Disorders, 169-195. New York: Guilford Press.

52. Dual Diagnosis Issues depression trauma history; PTSD schizophrenia medication strategies

53. PTSD Influence in Early Tx Aim: determine tx adherence relative to frequency of violence and PTSD in MMT pts, male & female 96 pts; over 2/3 exposed to one or more violent traumatic events Trauma or PTSD did not predict dropout rates Those with current PTSD had significantly more ongoing drug use at 3 months, especially cocaine (Hein et al, 2000)

54. Continued heroin, alcohol, and other drug use patient and provider expectations enhancing motivation cocaine use alcohol use medical comorbidity; AIDS, chronic pain controversies about discharge

55. Psychological Issues AOD use in family of origin high frequency of childhood physical and sexual abuse recognition and appropriate expression of feelings issues of self-care, self-soothing

56. Women�s Issues remove practical barriers: transportation, child care intimate relationships as primary hazard sexual issues contraceptive practices

57. Family/Couples Work engaging family, significant others education about addiction and MMT develop existing and new support structures couples issues parenting classes

58. HIV/AIDS impact on MMT staff; providing support regular assessment of staff attitudes and knowledge integrating primary care promoting medication compliance impact of dementia on treatment

59. MMT and 12-Step Programs benefits and hazards simulated meetings as a launching strategy meetings in the community Vincent Dole and Bill W. other types of self-help advocacy groups

60. Making Residential Treatment Available to Methadone Patients Some clients need higher level of care Issues for the methadone program Issues for the residential program Security issues Documentation issues Funding barriers