Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone dr shabeel pn
Presentation Goals <ul><li>Use of medication to treat opioid dependence during pregnancy </li></ul><ul><li>Review of publi...
Studies of Medication During Pregnancy <ul><li>Controversial </li></ul><ul><li>Some say unethical </li></ul><ul><li>Stigma...
Goals of Opioid Agonist Treatment  <ul><li>Cessation of opioid use </li></ul><ul><li>Stabilize intrauterine environment </...
Methadone is effective during pregnancy <ul><li>Methadone is  recommended  for the treatment of opioid dependent pregnant ...
<ul><li>Neonatal Abstinence Syndrome (NAS) </li></ul><ul><ul><li>Neuralgic excitability  (hyperactivity, irritability, sle...
The NAS of Opioid Exposed Neonates <ul><li>55-90% exhibit  NAS </li></ul><ul><li>Methadone dose relationship to NAS severi...
Buprenorphine <ul><li>Subutex or Suboxone </li></ul><ul><li>Buprenorphine reported to produce less physical dependence in ...
Case Reports and Open-Label Studies <ul><li>Since 1995, 23 reports of prenatal exposure to buprenorphine  </li></ul><ul><l...
Purpose <ul><li>Compare methadone and buprenorphine in pregnant opioid-dependent women and to provide preliminary safety a...
Randomized Controlled Study <ul><ul><li>Double-blind (staff and patient) </li></ul></ul><ul><ul><li>Double-dummy (two medi...
Setting: Center for Addiction & Pregnancy <ul><li>Interdisciplinary Approach  </li></ul><ul><ul><li>Psychiatry </li></ul><...
Criteria <ul><li>Inclusion: </li></ul><ul><ul><li>18 - 40 years of age </li></ul></ul><ul><ul><li>Gestational age 16 - 30 ...
Criteria <ul><li>Exclusion: </li></ul><ul><ul><li>Methadone positive urine at admission </li></ul></ul><ul><ul><li>DSM IV ...
Primary Outcome Measures    Infant <ul><li>Neonatal Abstinence Syndrome (NAS) </li></ul><ul><li>Length of Hospital Stay  (...
Selected Secondary Outcome Measures <ul><li>Maternal  </li></ul><ul><ul><li>Days of treatment </li></ul></ul><ul><ul><li>P...
Patient Flow Number screened 1490 Not Qualify Initially 1433 Qualify and sign consent 57 Randomized  30 Buprenorphine 15 M...
Induction <ul><li>Patients stabilized on immediate release morphine (IRM) prior to randomization </li></ul><ul><li>Is tran...
Induction Adapted from Jones,H.E. et al., In press. Drug and Alcohol Dependence
Maternal Outcome Drug Use During Pregnancy opioid  15.6 16.7 cocaine  11.2 15.2 amphetamine   0.0   0.0 barbiturates     0...
Maternal Characteristics % African-American 63.6 88.9 Gestation (weeks) 23.6 22.8 Education (yrs) 10.0 10.3 % Employed    ...
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 T...
Birth Outcomes Methadone N=11 Buprenorphine N=9 deliveries (10 babies) * data safety monitoring board recommended removing...
NAS Time Course
Limitations of Study <ul><li>Small sample size </li></ul><ul><li>I/E criteria limits generalizability </li></ul><ul><li>Ni...
Conclusions <ul><li>Both methadone and buprenorphine provide positive benefits to mothers </li></ul><ul><li>100% of infant...
Bottom Line <ul><li>Both medications have strong support to document safety and efficacy for mother and infant </li></ul><...
Future Directions <ul><li>Multi-center trial comparing methadone and buprenorphine </li></ul><ul><li>8 sites submitted app...
Upcoming SlideShare
Loading in …5
×

Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone

2,130 views

Published on

Published in: Education

Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone

  1. 1. Treating Pregnant Opioid Dependent Women: Examining Buprenorphine and Methadone dr shabeel pn
  2. 2. Presentation Goals <ul><li>Use of medication to treat opioid dependence during pregnancy </li></ul><ul><li>Review of published prenatal buprenorphine exposure data </li></ul><ul><li>Randomized double-blind study </li></ul>
  3. 3. Studies of Medication During Pregnancy <ul><li>Controversial </li></ul><ul><li>Some say unethical </li></ul><ul><li>Stigma associated with medication treatment for pregnant women is severe </li></ul>
  4. 4. Goals of Opioid Agonist Treatment <ul><li>Cessation of opioid use </li></ul><ul><li>Stabilize intrauterine environment </li></ul><ul><li>Increased prenatal care compliance </li></ul><ul><li>Enhanced pregnancy outcomes </li></ul>
  5. 5. Methadone is effective during pregnancy <ul><li>Methadone is recommended for the treatment of opioid dependent pregnant women </li></ul><ul><li>Over 30 years of experience and research </li></ul><ul><li>Does not appear to have teratogenic potential </li></ul>
  6. 6. <ul><li>Neonatal Abstinence Syndrome (NAS) </li></ul><ul><ul><li>Neuralgic excitability (hyperactivity, irritability, sleep disturbance) </li></ul></ul><ul><ul><li>Gastrointestinal dysfunction </li></ul></ul><ul><ul><li>(uncoordinated sucking/swallowing, </li></ul></ul><ul><ul><li>vomiting) </li></ul></ul><ul><ul><li>Autonomic Signs (fever, sweating, nasal stuffiness) </li></ul></ul>Methadone is not a “Magic Bullet” Medication
  7. 7. The NAS of Opioid Exposed Neonates <ul><li>55-90% exhibit NAS </li></ul><ul><li>Methadone dose relationship to NAS severity is inconsistent </li></ul><ul><li>Onset within 48 to 72 hours after birth </li></ul><ul><li>Subacute signs for a year </li></ul>
  8. 8. Buprenorphine <ul><li>Subutex or Suboxone </li></ul><ul><li>Buprenorphine reported to produce less physical dependence in adults </li></ul>Full Agonist Full Antagonist Heroin Methadone Morphine Naltrexone Naloxone Buprenorphine Nalmefene
  9. 9. Case Reports and Open-Label Studies <ul><li>Since 1995, 23 reports of prenatal exposure to buprenorphine </li></ul><ul><li>Approximately 338 babies and number of cases ranged from 1 to 153 (median=6) </li></ul><ul><li>61% NAS with 48% requiring treatment </li></ul><ul><ul><li>NAS appears in 12-48 hrs, </li></ul></ul><ul><ul><li>peaks 72-96 hrs </li></ul></ul><ul><ul><li>Duration 120-168 hrs </li></ul></ul>
  10. 10. Purpose <ul><li>Compare methadone and buprenorphine in pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial </li></ul>
  11. 11. Randomized Controlled Study <ul><ul><li>Double-blind (staff and patient) </li></ul></ul><ul><ul><li>Double-dummy (two medications) </li></ul></ul><ul><ul><li>Two groups: Methadone or Buprenorphine </li></ul></ul><ul><ul><li>Flexible dosing </li></ul></ul><ul><ul><ul><li>Methadone 20-100 mg </li></ul></ul></ul><ul><ul><ul><li>Buprenorphine 4-24 mg </li></ul></ul></ul>
  12. 12. Setting: Center for Addiction & Pregnancy <ul><li>Interdisciplinary Approach </li></ul><ul><ul><li>Psychiatry </li></ul></ul><ul><ul><li>Obstetrics </li></ul></ul><ul><ul><li>Pediatrics </li></ul></ul><ul><ul><li>Nursing </li></ul></ul>
  13. 13. Criteria <ul><li>Inclusion: </li></ul><ul><ul><li>18 - 40 years of age </li></ul></ul><ul><ul><li>Gestational age 16 - 30 weeks </li></ul></ul><ul><ul><li>Opioid dependent (DSM-IV, SCID I) </li></ul></ul><ul><ul><li>Opioid positive urine </li></ul></ul>
  14. 14. Criteria <ul><li>Exclusion: </li></ul><ul><ul><li>Methadone positive urine at admission </li></ul></ul><ul><ul><li>DSM IV axis I current diagnosis other than psychoactive substance use </li></ul></ul><ul><ul><li>Serious medical or psychiatric illness </li></ul></ul><ul><ul><li>Diagnosis of preterm labor </li></ul></ul><ul><ul><li>Congenital fetal malformation </li></ul></ul><ul><ul><li>Current alcohol abuse/dependence </li></ul></ul><ul><ul><li>Benzodiazepine use </li></ul></ul><ul><ul><ul><li>(8 or more times/month and/or 2 or more times /week) </li></ul></ul></ul>
  15. 15. Primary Outcome Measures Infant <ul><li>Neonatal Abstinence Syndrome (NAS) </li></ul><ul><li>Length of Hospital Stay (LOS) </li></ul>
  16. 16. Selected Secondary Outcome Measures <ul><li>Maternal </li></ul><ul><ul><li>Days of treatment </li></ul></ul><ul><ul><li>Prenatal care visits </li></ul></ul><ul><ul><li>Illicit drug use </li></ul></ul><ul><li>Infant </li></ul><ul><ul><li>Physical birth parameters </li></ul></ul>
  17. 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. 18. Induction <ul><li>Patients stabilized on immediate release morphine (IRM) prior to randomization </li></ul><ul><li>Is transition from IRM to methadone or buprenorphine similar? </li></ul><ul><li>Withdrawal scores over first 3 days appeared mild for both medications </li></ul>
  19. 19. Induction Adapted from Jones,H.E. et al., In press. Drug and Alcohol Dependence
  20. 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. 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. 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. 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. 24. NAS Time Course
  25. 25. Limitations of Study <ul><li>Small sample size </li></ul><ul><li>I/E criteria limits generalizability </li></ul><ul><li>Nicotine exposure and effect on NAS needs more study </li></ul><ul><li>Long-term outcomes beyond scope of study </li></ul>
  26. 26. Conclusions <ul><li>Both methadone and buprenorphine provide positive benefits to mothers </li></ul><ul><li>100% of infants had NAS signs/symptoms </li></ul><ul><li>Tendency for fewer buprenorphine-exposed babies to be treated for NAS </li></ul><ul><li>Significantly fewer days of hospitalization with buprenorphine exposure </li></ul>
  27. 27. Bottom Line <ul><li>Both medications have strong support to document safety and efficacy for mother and infant </li></ul><ul><li>NAS is only part of the complete risk:benefit ratio </li></ul><ul><li>A greater range of medication options will improve the treatment of pregnant women </li></ul>
  28. 28. Future Directions <ul><li>Multi-center trial comparing methadone and buprenorphine </li></ul><ul><li>8 sites submitted applications </li></ul><ul><li>May provide data needed to change FDA labeling for methadone and buprenorphine </li></ul><ul><li>Develop infrastructure for studying other medications and women’s health issues during pregnancy </li></ul>

×