1. Medication Assisted Treatment (MAT) Issues for Women Susan F. Neshin, MD Medical Director JSAS Healthcare, Inc. Asbury Park, NJ E-mail: jsasmd@aol.com

2. What is MAT? MAT=Medication Assisted Treatment EUPHEMISM for opioid maintenance therapy –Methadone –Buprenorphine Broaden definition –Naltrexone –Medication for other drug dependencies

3. Medications Development Division Branch of National Institute on Drug Abuse (NIDA) Developing new medications Addiction as a brain disease Drug craving as a physiologic phenomenon

4. Rationale for MAT/OMT For Chronic Opioid Dependence Dole’s concept of metabolic derangement Current concept of neuronal adaptations to repeated exposures of the drug Pre-existing vulnerability and/or consequence of opioid use Corrective, not curative

5. On/Off - Non-Tolerant Drug States Mood/Effect Scale “ON” Drug Effect “OFF” No Drug Effect; “Normal” Overdose Intoxication Euphoria “Normophoria” Dysphoria Opioid Maintenance Pharmacotherapy - A Course for Clinicians 5

6. Dose Response Time “Loaded” “High” Normal Range “Comfort Zone” “Sick” Heroin Simulated 24 Hr. Dose/Response With established heroin tolerance/dependence 0 hrs. 24 hrs. “Abnormal Normality” Subjective w/d Objective w/d Opioid Maintenance Pharmacotherapy - A Course for Clinicians 6

7. Dose Response Time “Loaded” “High” Normal Range “Comfort Zone” “Sick” Methadone Simulated 24 Hr. Dose/Response At steady-state in tolerant patient 0 hrs. 24 hrs. “Abnormal Normality” Subjective w/d Objective w/d Opioid Maintenance Pharmacotherapy - A Course for Clinicians 7

8. Goals for Pharmacotherapy Prevention or reduction of withdrawal symptoms Prevention or reduction of drug craving Prevention of relapse to use of addictive drug Restoration to or toward normalcy of any physiological function disrupted by drug addiction

9. Importance of Dose Adequacy!

10. Recent Heroin Use by Current Methadone Dose Current Methadone Dose mg/day % Heroin Use J. C. Ball, November 18, 1988

11. Retention in Treatment Relative to Dose 80 + mg 60-79 mg < 60 mg Adapted from Caplehorn & Bell - The Medical Journal of Australia

12. Impact of Maintenance Treatment Reduction death rates (Grondblah, ‘90) Reduction IVDU (Ball & Ross, ‘91) Reduction crime days (Ball & Ross) Reduction rate of HIV seroconversion (Bourne, ‘88; Novick ‘90,; Metzger ‘93) Reduction relapse to IVDU (Ball & Ross) Improved employment, health, & social function

13. DEATH RATES IN TREATED AND UNTREATED HEROIN ADDICTS Slide data courtesy of Frank Vocci, MD, NIDA - Reference: Grondblah, L. et al. ACTA PSCHIATR SCAND, P. 223-227, 1990 % Annual Death Rates 13

14. Impact of MMT on IV Drug Use for 388 Male MMT Patients in 6 Programs PERCENT IV USERS 0 100 LAST ADDICTION PERIOD ADMISSION 100% 81.4% Pre- | 1st Year | 2nd Year | 3rd Year | 4th Year Admission * * 63.3% 41.7% 28.9% Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991

15. Crime among 491 patients before and during MMT at 6 programs Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991 Crime Days Per Year

16. HIV CONVERSION IN TREATMENT 18 month HIV conversion by treatment retention Source: Metzger, D. et. al. J of AIDS 6:1993. p.1053

17. OMT as Treatment of Choice for Chronic Relapsing Opioid Addict Concept of “prolonged abstinence” –Hyper-reactivity to stress –Dysphoria/craving increase vulnerability to relapse

18. Relapse to IV drug use after MMT 105 male patients who left treatment Percent IV Users Treatment Months Since Stopping Treatment Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991

19. The Medications Methadone –Long-acting full opioid agonist –Orally effective –Can be taken once a day –Prescribed and dispensed at licensed OTPs

20. The Medications Buprenorphine –Approved by FDA in October, 2002 –Result of DATA 2000 –Long-acting partial opioid agonist –Sublingually effective –Can be taken once a day or less frequently –Prescribed by private practitioner with waiver

21. The Medications Naltrexone –Long-acting opioid antagonist –Orally effective –Can be taken once a day or less frequently –Benefits subgroups of opioid addicts

22. Addiction as a Biopsychosocial Disease OMT addresses the biological aspect Psychosocial aspects addressed –Substance abuse counseling –Mental health treatment –Support and self-help groups Accreditation standards –Should improve treatment –Eliminate “gas and go” model

23. Women’s Issues Higher levels of dual diagnosis than men Childcare Transportation Domestic Violence Educational/Vocational Financial Pregnancy

24. How to Address Women’s Issues Accreditation standards Variable levels of resources Women’s Set-Aside funds One-stop shopping

25. Dual Diagnosis Depression/mood disorders Anxiety disorders/PTSD Eating disorders Symptoms –Guilt and shame –Low self esteem

26. Dual Diagnosis Train counseling staff Availability of therapist Availability of psychiatrist Staff with expertise in “survivor” issues –Lifetime prevalence of drug abuse > 4 times greater in women who report history of sexual assault Support/therapy groups

27. Childcare Issues Most women in treatment are of childbearing age Children as barrier to treatment Services to address –Children welcome –On-site child care –Parenting classes

28. Domestic Violence Train staff Facilitate referral to shelter when appropriate Support/therapy group

29. Educational/Vocational Issues Most women in treatment are “undereducated” and “underemployed” Services to address: –Train staff about community resources/state-funded programs –On-site vocational counselor –Address “sex for drugs” issues

30. Financial Issues Treatment is expensive Proprietary vs. publicly-funded non-profit programs Services to address patient issues –Accept Medicaid as payment –Allow for reduced fee/indigency –Counsel on budgeting –Counselor referrals to/interventions with local service agencies

31. Financial Issues Program issues –Fund raising –Lobbying for higher state/federal funding

32. Pregnancy Comprehensive OMT with adequate prenatal care can reduce the incidence of obstetrical and fetal complications, in utero growth retardation, and neonatal morbidity and mortality (Finnegan, 1991).

33. Model Perinatal Program On-site prenatal care On-site well-baby care On-site child care Educational groups –Pregnancy/medical issues –Methadone and pregnancy –Effects of drugs of abuse, including alcohol and nicotine, on fetus

34. Model Perinatal Program Educational groups--continued –Nutrition –Baby care –Parenting skills--include fathers –Contraception/Family Planning Counseling on pregnancy termination

35. Perinatal Addiction Withdrawal? - Rarely appropriate during pregnancy (ASAM 1990) – Same recidivism as non-pregnant opioid addicts (Finnegan, 1990) –Slow withdrawal between 14 and 32 weeks (Kaltenbach, 1992) Dose of methadone should be individually determined and adequate to control craving and prevent withdrawal syndrome

36. Perinatal Addiction MMT patients who become pregnant should be continued at established dose. A mid- trimester reduction may be appropriate in anticipation of 3rd trimester dose increase. Altered pharmacokinetics during 3rd trimester often require dose increases and often a split dose to “flatten the curve” and improve maternal and fetal stability.

37. Perinatal Addiction There is no consistent correlation between maternal methadone dose and the severity of neonatal withdrawal syndrome (Stimmel et al., 1982). Protocols are available for scoring signs of opioid withdrawal to guide the appropriate use of medications to facilitate a safe and comfortable withdrawal of the passively addicted neonate (Finnegan, 1985).

38. Perinatal Addiction Breast-feeding may be encouraged during MMT - if not otherwise contraindicated (Kaltenbach, 1992). Multiple longitudinal studies find that methadone-exposed infants score well within the normal range of development (Kaltenbach, 1992).

39. Addressing Stigma EDUCATE OURSELVES! –“I don’t believe in methadone!” –ASAM addressing physician bias Arizona study -- 96% refusal to treat or give pain meds Example of physician opioid addict

40. Addressing Stigma EDUCATE OURSELVES!--continued –Need to educate therapeutic communities, Minnesota model programs –Need to educate Twelve Step community Methadone/buprenorphine as prescribed medications rather than drugs of abuse Patients on OMT can work a program of recovery

41. Addressing Stigma Educate service agencies and the general public –Arizona study -- 66% refused employment or lost job Educate patients about the chronic disease concept –Methadone/buprenorphine as corrective, not curative Educate family members

42. Addressing Stigma Publicly funded programs should be mandated to accept patients on OMT Private programs should be encouraged to accept patient on OMT –Great need for residential treatment/halfway houses for women (pregnant or non-pregnant) and their children

43. Addressing Stigma Patients should be encouraged to get involved in advocacy Patients need to risk divulging status to treatment providers with support from program staff

44. Transportation Issues Lack of transportation as barrier to treatment Clinics in “out of the way” areas Services to address –Use of medical transportation for Medicaid patients –Site program close to public transportation –Give “take-homes” when earned –Van service –Home medication/family member pick- up for homebound patients

45. Perinatal Addiction -6 Obstacle and barriers to MMT must be removed for the pregnant patients. More research is needed on innovative models of treatment including medically supervised withdrawal during pregnancy with residential care, intensive relapse prevention and monitoring, high-risk prenatal care. When appropriate hospitals, clinics and individual obstetricians could provide methadone maintenance. Opioid Maintenance Pharmacotherapy - A Course for Clinicians

46. Withdrawal during Pregnancy  The patient refuses to be placed on methadone maintenance.  The patient lives in an area where methadone maintenance is not available.  The patient has been stable during treatment & requests withdrawal prior to delivery.  The patient has been so disruptive to the treatment setting that the treatment of other patients is jeopardized, necessitating the removal of the patient from the program. Opioid Maintenance Pharmacotherapy - A Course for Clinicians Jarvis & Schnoll,1994