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Drug Treatment Issues in Drug-Dependent, Pregnant Women

Drug Treatment Issues in Drug-Dependent, Pregnant Women . Hendrée E. Jones, Ph.D. Department of Psychiatry and Behavioral Sciences Johns Hopkins University School of Medicine Baltimore, Maryland. Disclosure.

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Drug Treatment Issues in Drug-Dependent, Pregnant Women

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  1. Drug Treatment Issues in Drug-Dependent, Pregnant Women Hendrée E. Jones, Ph.D. Department of Psychiatry and Behavioral SciencesJohns Hopkins University School of Medicine Baltimore, Maryland

  2. Disclosure • During this presentation at the annual APA meeting, Dr. Jones will be discussing the uses of commercial products not yet approved for this purpose by the FDA. She has no actual or potential conflict of interest in regards to this program. APA May 5, 2004

  3. Presentation Goals • Use of medication to treat opioid dependence during pregnancy • Clinical trial of methadone and buprenorphine during pregnancy • Behavioral interventions enhance maternal outcomes APA May 5, 2004

  4. Studies of Medication During Pregnancy • Controversial • Some say unethical • Stigma associated with medication treatment for pregnant women is severe APA May 5, 2004

  5. Goals of Opioid Agonist Treatment • Cessation of opioid use • Stabilize intrauterine environment • Increased prenatal care compliance • Enhanced pregnancy outcomes APA May 5, 2004

  6. Methadone is effective during pregnancy • Methadone is recommended for the treatment of opioid-dependent women • Over 30 years of experience and research • Not appear to have teratogenic potential APA May 5, 2004

  7. Neonatal Abstinence Syndrome (NAS) • Neuralgic excitability (hyperactivity, irritability, sleep disturbance) • Gastrointestinal dysfunction (uncoordinated sucking/swallowing, vomiting) • Autonomic Signs (fever, sweating, nasal stuffiness) APA May 5, 2004

  8. 55-90% exhibit NAS Methadone dose relationship to NAS severity is inconsistent Onset within 48 to 72 hours after birth Subacute signs up to 12 months The NAS of Opioid-Exposed Neonates APA May 5, 2004

  9. Buprenorphine • A derivative of thebaine • Marketed as Subutex or Suboxone Full Full Antagonist Agonist Heroin Buprenorphine Nalmefene Naloxone Morphine Naltrexone Methadone APA May 5, 2004

  10. Buprenorphine • Birth outcomes improved with agonist therapy (e.g., methadone) • Withdrawal associated with agonist therapy can require hospitalization • Buprenorphine reported to produce less physical dependence in adults APA May 5, 2004

  11. Case Reports and Open-Label Studies • Since 1995, 23 reports of prenatal exposure to buprenorphine • 22 reports from Europe and 1 from U.S. • Number of cases ranged from 1 to 153 (median=6) • TOTAL 338 babies APA May 5, 2004

  12. Outline • Use of medication to treat opioid dependence during pregnancy • Clinical trial of methadone and buprenorphine during pregnancy • Behavioral interventions enhance mother and child outcomes APA May 5, 2004

  13. Randomized Controlled Study • Double-blind (staff and patient) • Double-dummy (two medications) • Two groups: Methadone or Buprenorphine • Flexible dosing • Methadone 40-100 mg • Buprenorphine 4-24 mg APA May 5, 2004

  14. Setting: Center for Addiction & Pregnancy • Interdisciplinary Approach • Psychiatry • Obstetrics • Pediatrics • Nursing APA May 5, 2004

  15. Criteria • Inclusion: • 18 - 40 years of age • Gestational age 16 - 30 weeks • Opioid dependent (DSM-IV, SCID I) • Recent opioid use • Opioid positive urine APA May 5, 2004

  16. Criteria • Exclusion: • Methadone positive urine at admission • DSM IV axis I current diagnosis other than psychoactive substance use • Serious medical or psychiatric illness • Diagnosis of preterm labor • Congenital fetal malformation • Current alcohol abuse/dependence • Benzodiazepine use • (8 or more times/month and/or 2 or more times/week) APA May 5, 2004

  17. Primary Outcome Measures Infant • Neonatal Abstinence Syndrome (NAS) • Length of Hospital Stay (LOS) APA May 5, 2004

  18. Selected Secondary Outcome Measures • Maternal • Days of treatment • Prenatal care visits • Illicit drug use • Infant • Physical birth parameters APA May 5, 2004

  19. Patient Flow Number screened 1490 Not Qualify Initially 1433 Qualify and sign consent 57 Randomized 30 Buprenorphine 15 Methadone 15 Buprenorphine 9 Methadone 11 APA May 5, 2004

  20. Induction • Patients stabilized on immediate release morphine (IRM) prior to randomization • Is transition from IRM to methadone or buprenorphine similar? • Withdrawal scores over first 3 days appeared mild for both medications APA May 5, 2004

  21. Maternal OutcomeDrug Use During Pregnancy Methadone N=11 Buprenorphine N=9 % opioid + 15.6 16.7 % cocaine + 11.2 15.2 % amphetamine + 0.0 0.0 % barbiturates + 0.0 0.0 % benzo + 0.4 2.5 % THC+ 7.5 0.0 APA May 5, 2004

  22. Maternal Characteristics Methadone N=11 Buprenorphine N=9 % African-American 63.6 88.9 EGA (weeks) 23.6 22.8 Education (yrs) 10.0 10.3 % Employed 0.0 0.0 Age (yrs) 30.3 30.0 APA May 5, 2004

  23. Maternal Outcomes Methadone N=11 Buprenorphine N=9 Days in Treatment 99.9 115.6 Prenatal care visits 3.4 3.6 LOS mom 2.2 2.2 C section % 9.1 11.1 Tox. + delivery (mom)% 9.1 0.0 normal presentation % 100 100 Preterm birth % 9.1 0.0 Gestational age delivery 38.8 38.8 Ave. dose at delivery (mg) 79.1 18.7 APA May 5, 2004

  24. Birth Outcomes Methadone N=11 Buprenorphine N=9 deliveries (10babies) % Treated45.5 20.0 Birth Weight (gm)* 3001.8 3530.4 LOS baby 8.1 6.8 % NICU treatment 18.0 10.0 APGAR 1 8.3 8.1 APGAR 5 8.9 8.7 Length (cm)* 49.6 52.8 Head Cir. (cm)* 33.2 34.9 %Tox + (Baby)* 0.0 20.0 * data safety monitoring board recommended removing twin data from these variables APA May 5, 2004

  25. Limitations of Study • Small sample size • I/E criteria limits generalizability • Nicotine exposure and effect on NAS needs more study • Long-term outcomes beyond scope of study APA May 5, 2004

  26. Conclusions • Both methadone and buprenorphine provide positive benefits to mothers • 100% of infants had NAS signs/symptoms • Tendency for fewer buprenorphine-exposed babies to be treated for NAS • Significantly fewer days of hospitalization with buprenorphine exposure APA May 5, 2004

  27. Bottom Line • Both medications have strong support to document safety and efficacy for mother and infant • NAS is only part of the complete risk:benefit ratio • More medication options will improve the treatment of pregnant women APA May 5, 2004

  28. Issues Pregnant, Drug-Dependent Women Face • Unstable housing • Victimization and violence physical sexual emotional • Severe stigma • Other psychiatric issues • Multigenerational drug use • Lack of education • Maladaptive behaviors poor self-control trust issues • Legal • Parenting APA May 5, 2004

  29. Presentation Goals • Use of medication to treat opioid dependence during pregnancy • Clinical trial of methadone and buprenorphine during pregnancy • Behavioral Interventions enhance maternal outcomes APA May 5, 2004

  30. Types of Behavioral Interventions Examined at CAP • Contingency Management • Rewards for drug-abstinence include housing, gift certificates, goods and services • Community Reinforcement Approach • Motivational Interviewing APA May 5, 2004

  31. Relationships as Barriers to Treatment • Female drug use starts and continues in context of male romantic relationships • Level of partner support impacts outcomes among pregnant methadone-maintained women (Jeremy, 1984; Marcus, 1984) APA May 5, 2004

  32. Women’s Treatment Retention • Mean relationship of 4 yrs + • Drug using partners • -less employed • - less supportive • of woman’s treatment • -more legal involvement • -more dental and • medical needs * * P<0.05; Data adapted from Drug and Alcohol Dependence (2003) APA May 5, 2004

  33. Partner Treatment • 2 group randomized design • Control-- receive weekly support group • Intervention -- • Methadone or detox + aftercare • MI type counseling • abstinent contingent vouchers • 1, 3, and 6 month follow-up interviews APA May 5, 2004

  34. Partner Results • 35 years old • 73% unemployed • 59% African-American • 72% used cocaine • 94% believed they were the father of the baby APA May 5, 2004

  35. Intervention Increases Drug Abstinence in Male Partners * *p<.05 APA May 5, 2004

  36. Intervention Increases Drug Abstinence in Women * *p<.05 APA May 5, 2004

  37. Intervention Increases Partner Support of the Woman * *p<.05 APA May 5, 2004

  38. Conclusions • Interventions are available to engage and retain male partners • Treating the male partner is associated with enhanced treatment outcomes for pregnant opioid-dependent women APA May 5, 2004

  39. Take Home Message • Pregnancy is area where most certainty is desired, but there is often the least data • More medication options will improve the treatment of pregnant women • Engaging and treating the male drug using partners can improve the outcomes of women in drug treatment APA May 5, 2004

  40. Acknowledgements • Rolley “Ed” Johnson • Patients and infants • NIDA R01 DA12220 and DA13496 • Co-Investigators • Staff at Center for Addiction and Pregnancy • Staff at BPRU APA May 5, 2004

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