Medication Assisted Treatment (MAT) in Pregnant Women

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

2. Overview of Presentation • What is MAT? • Rationale for MAT • Importance of Dose Adequacy • Impact of MAT • The Medications • Women’s Issues/PREGNANCY • Addressing Stigma

3. What is MAT? • MAT=Medication Assisted Treatment in context of substance abuse treatment • EUPHEMISM for opioid maintenance therapy • Methadone • Buprenorphine • Broaden definition • Naltrexone • Medication for other drug dependencies • Medication in the treatment of chronic disease

4. 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

5. Rationale for MAT/OMTFor 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

6. On/Off - Non-Tolerant Drug States Overdose Intoxication Euphoria “Normophoria” Dysphoria “ON” Drug Effect Mood/Effect Scale “OFF” No Drug Effect; “Normal” 6 Opioid Maintenance Pharmacotherapy - A Course for Clinicians

7. Heroin Simulated 24 Hr. Dose/ResponseWith established heroin tolerance/dependence “Loaded” “High” “Abnormal Normality” Normal Range“Comfort Zone” Dose Response Subjective w/d “Sick” Objective w/d Time 0 hrs. 24 hrs. 7 Opioid Maintenance Pharmacotherapy - A Course for Clinicians

8. Methadone Simulated 24 Hr. Dose/ResponseAt steady-state in tolerant patient “Loaded” “High” “Abnormal Normality” Normal Range“Comfort Zone” Dose Response Subjective w/d “Sick” Objective w/d Time 0 hrs. 24 hrs. 8 Opioid Maintenance Pharmacotherapy - A Course for Clinicians

9. 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

10. Importance of Dose Adequacy!

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

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

13. 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

14. DEATH RATES IN TREATED AND UNTREATED HEROIN ADDICTS % Annual Death Rates Slide data courtesy of Frank Vocci, MD, NIDA - Reference: Grondblah, L. et al. ACTA PSCHIATR SCAND, P. 223-227, 1990 14

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

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

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

18. OMT as Treatment of Choicefor Chronic Relapsing Opioid Addict • Concept of “prolonged abstinence” • Hyper-reactivity to stress • Dysphoria/craving increase vulnerability to relapse

19. Relapse to IV drug use after MMT105 male patients who left treatment Percent IV Users Treatment Months Since Stopping Treatment Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991

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

21. 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

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

23. 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

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

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

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

27. 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

28. 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

29. 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

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

31. 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

32. 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

33. Financial Issues • Program issues • Fund raising • Lobbying for higher state/federal funding

34. Considerations for Treatment of Pregnant Opiate Addict • Tolerance level • Chronicity of use • Route of administration • Pregnancy history • Motivational level • Recovery environment • Ideal vs. Reality

35. OMT/MAT as Standard of Care • Steady levels of opiates normalize neuroendocrine functioning and prevent fetal distress • Decreases rates of pregnancy complications, e.g. miscarriage, stillbirth, IUGR, abruptio placenta, infection, hemorrhage • Improves prenatal care • Allows for psychosocial interventions to improve level of functioning

36. Perinatal Addiction • Importance of pregnancy testing at intake • Priority admission should be given to pregnant patients • Family planning as counseling issue with periodic pregnancy testing, especially during medically supervised withdrawal • Dose of methadone should be individually determined and adequate to control craving and prevent withdrawal syndrome

37. 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.

38. 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).

39. 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).

40. Perinatal Addiction • Obstacles 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.

41. Withdrawal during Pregnancy • Rarely appropriate during pregnancy (ASAM 1990) • Same recidivism as non-pregnant opioid addicts • Slow withdrawal between 14 and 32 week • Patient lives in an area where MM is not available. • Patient refuses to be placed on MM. • Patient has been stable and requests withdrawal prior to delivery.

42. Withdrawal during Pregnancy • No harm reduction with OMT • 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.

43. 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).

44. 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