Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone

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  • 1. Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone dr shabeel pn
  • 2. Presentation Goals
    • Use of medication to treat opioid dependence during pregnancy
    • Review of published prenatal buprenorphine exposure data
    • Randomized double-blind study
  • 3. Studies of Medication During Pregnancy
    • Controversial
    • Some say unethical
    • Stigma associated with medication treatment for pregnant women is severe
  • 4. Goals of Opioid Agonist Treatment
    • Cessation of opioid use
    • Stabilize intrauterine environment
    • Increased prenatal care compliance
    • Enhanced pregnancy outcomes
  • 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
  • 6.
    • Neonatal Abstinence Syndrome (NAS)
      • Neuralgic excitability (hyperactivity, irritability, sleep disturbance)
      • Gastrointestinal dysfunction
      • (uncoordinated sucking/swallowing,
      • vomiting)
      • Autonomic Signs (fever, sweating, nasal stuffiness)
    Methadone is not a “Magic Bullet” Medication
  • 7. The NAS of Opioid Exposed Neonates
    • 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
  • 8. Buprenorphine
    • Subutex or Suboxone
    • Buprenorphine reported to produce less physical dependence in adults
    Full Agonist Full Antagonist Heroin Methadone Morphine Naltrexone Naloxone Buprenorphine Nalmefene
  • 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
  • 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
  • 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
  • 12. Setting: Center for Addiction & Pregnancy
    • Interdisciplinary Approach
      • Psychiatry
      • Obstetrics
      • Pediatrics
      • Nursing
  • 13. Criteria
    • Inclusion:
      • 18 - 40 years of age
      • Gestational age 16 - 30 weeks
      • Opioid dependent (DSM-IV, SCID I)
      • Opioid positive urine
  • 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)
  • 15. Primary Outcome Measures Infant
    • Neonatal Abstinence Syndrome (NAS)
    • Length of Hospital Stay (LOS)
  • 16. Selected Secondary Outcome Measures
    • Maternal
      • Days of treatment
      • Prenatal care visits
      • Illicit drug use
    • Infant
      • Physical birth parameters
  • 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
  • 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
  • 19. Induction Adapted from Jones,H.E. et al., In press. Drug and Alcohol Dependence
  • 20. Maternal Outcome Drug Use During Pregnancy 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 Methadone N=11 Buprenorphine N=9 % + Urine Samples
  • 21. Maternal Characteristics % 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 Methadone N=11 Buprenorphine N=9
  • 22. Maternal Outcomes 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 Methadone N=11 Buprenorphine N=9
  • 23. Birth Outcomes Methadone N=11 Buprenorphine N=9 deliveries (10 babies) * data safety monitoring board recommended removing twin data from these variables % Treated for NAS 45.5 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
  • 24. NAS Time Course
  • 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
  • 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
  • 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
  • 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