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Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone

Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone. Hendrée E. Jones, Ph.D. Associate Professor Department of Psychiatry and Behavioral Sciences Johns Hopkins University School of Medicine Baltimore, Maryland. Presentation Goals.

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Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone

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  1. Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone Hendrée E. Jones, Ph.D. Associate Professor Department of Psychiatry and Behavioral SciencesJohns Hopkins University School of Medicine Baltimore, Maryland

  2. Presentation Goals • Use of medication to treat opioid dependence during pregnancy • Review of published prenatal buprenorphine exposure data • Randomized double-blind study AATOD 2004

  3. Studies of Medication During Pregnancy • Controversial • Some say unethical • Stigma associated with medication treatment for pregnant women is severe AATOD 2004

  4. Goals of Opioid Agonist Treatment • Cessation of opioid use • Stabilize intrauterine environment • Increased prenatal care compliance • Enhanced pregnancy outcomes AATOD 2004

  5. Methadone is effective during pregnancy • Methadone is recommended for the treatment of opioid dependent pregnant women • Over 30 years of experience and research • Does not appear to have teratogenic potential AATOD 2004

  6. Methadone is not a “Magic Bullet” Medication • Neonatal Abstinence Syndrome (NAS) • Neuralgic excitability (hyperactivity, irritability, sleep disturbance) • Gastrointestinal dysfunction (uncoordinated sucking/swallowing, vomiting) • Autonomic Signs (fever, sweating, nasal stuffiness) AATOD 2004

  7. 55-90% exhibit NAS Methadone dose relationship to NAS severity is inconsistent Onset within 48 to 72 hours after birth Subacute signs for a year The NAS of Opioid Exposed Neonates AATOD 2004

  8. Buprenorphine • Subutex or Suboxone • Buprenorphine reported to produce less physical dependence in adults Full Full Antagonist Agonist Heroin Buprenorphine Nalmefene Naloxone Morphine Naltrexone Methadone AATOD 2004

  9. Case Reports and Open-Label Studies • Since 1995, 23 reports of prenatal exposure to buprenorphine • Approximately 338 babies and number of cases ranged from 1 to 153 (median=6) • 61% NAS with 48% requiring treatment • NAS appears in 12-48 hrs, • peaks 72-96 hrs • Duration 120-168 hrs AATOD 2004

  10. Purpose • Compare methadone and buprenorphine in pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial AATOD 2004

  11. Randomized Controlled Study • Double-blind (staff and patient) • Double-dummy (two medications) • Two groups: Methadone or Buprenorphine • Flexible dosing • Methadone 20-100 mg • Buprenorphine 4-24 mg AATOD 2004

  12. Setting: Center for Addiction & Pregnancy • Interdisciplinary Approach • Psychiatry • Obstetrics • Pediatrics • Nursing AATOD 2004

  13. Criteria • Inclusion: • 18 - 40 years of age • Gestational age 16 - 30 weeks • Opioid dependent (DSM-IV, SCID I) • Opioid positive urine AATOD 2004

  14. 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) AATOD 2004

  15. Primary Outcome Measures Infant • Neonatal Abstinence Syndrome (NAS) • Length of Hospital Stay (LOS) AATOD 2004

  16. Selected Secondary Outcome Measures • Maternal • Days of treatment • Prenatal care visits • Illicit drug use • Infant • Physical birth parameters AATOD 2004

  17. Patient Flow Number screened 1490 Not Qualify Initially 1433 Qualify and sign consent 57 Randomized 30 Buprenorphine 15 Methadone 15 Buprenorphine 9 Methadone 11 AATOD 2004

  18. 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 AATOD 2004

  19. Induction Adapted from Jones,H.E. et al., In press. Drug and Alcohol Dependence AATOD 2004

  20. Maternal OutcomeDrug Use During Pregnancy Methadone N=11 Buprenorphine N=9 % + Urine Samples opioid 15.6 16.7 cocaine 11.2 15.2 amphetamine 0.0 0.0 barbiturates 0.0 0.0 benzodiazepine 0.4 2.5 THC 7.5 0.0 AATOD 2004

  21. Maternal Characteristics Methadone N=11 Buprenorphine N=9 % African-American 63.6 88.9 Gestation (weeks) 23.6 22.8 Education (yrs) 10.0 10.3 % Employed 0.0 0.0 Age (yrs) 30.3 30.0 Smoked Cigarettes 81.8 77.8 AATOD 2004

  22. 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 AATOD 2004

  23. Birth Outcomes Methadone N=11 Buprenorphine N=9 deliveries (10 babies) % Treated for NAS45.5 20.0 Morphine Drops 93.1 23.6 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 * data safety monitoring board recommended removing twin data from these variables AATOD 2004

  24. NAS Time Course AATOD 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 AATOD 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 AATOD 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 • A greater range of medication options will improve the treatment of pregnant women AATOD 2004

  28. Future Directions • Multi-center trial comparing methadone and buprenorphine • 8 sites submitted applications • May provide data needed to change FDA labeling for methadone and buprenorphine • Develop infrastructure for studying other medications and women’s health issues during pregnancy AATOD 2004

  29. Acknowledgements • Patients and infants • Rolley “Ed” Johnson • NIDA R01 DA12220 (P.I.Johnson/Jones) • Co-Investigators • Staff at Center for Addiction and Pregnancy • Staff at BPRU AATOD 2004

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