1 / 29

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.

giona
Télécharger la présentation

Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related