Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the neonatal abstinence syndrome

Hendree E. Jones, Rolley E. Johnson, Donald R. Jasinski, Kevin E. O'Grady, Christian A. Chisholm, Robin E. Choo, Michael Crocetti, Robert Dudas, Cheryl Harrow, Marilyn A. Huestis, Lauren M. Jansson, Michael Lantz, Barry M. Lester, Lorraine Milio

Research output: Contribution to journalArticlepeer-review

218 Scopus citations


This study was designed to compare the neonatal abstinence syndrome (NAS) in neonates of methadone and buprenorphine maintained pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial. This randomized, double-blind, double-dummy, flexible dosing, parallel-group controlled trial was conducted in a comprehensive drug-treatment facility that included residential and ambulatory care. Participants were opioid-dependent pregnant women and their neonates. Treatment involved daily administration of either sublingual buprenorphine or oral methadone using flexible dosing of 4-24 mg or 20-100 mg, respectively. Primary a priori outcome measures were: (1) number of neonates treated for NAS; (2) amount of opioid agonist medication used to treat NAS; (3) length of neonatal hospitalization; and (4) peak NAS score. Two of 10 (20%) buprenorphine-exposed and 5 of 11 (45.5%) methadone-exposed neonates were treated for NAS (p = .23). Total amount of opioid-agonist medication administered to treat NAS in methadone-exposed neonates was three times greater than for buprenorphine- exposed neonates (93.1 versus 23.6; p = .13). Length of hospitalization was shorter for buprenorphine-exposed than for methadone-exposed neonates (p = .021). Peak NAS total scores did not significantly differ between groups (p = .25). Results suggest that buprenorphine is not inferior to methadone on outcome measures assessing NAS and maternal and neonatal safety when administered starting in the second trimester of pregnancy.

Original languageEnglish (US)
Pages (from-to)1-10
Number of pages10
JournalDrug and alcohol dependence
Issue number1
StatePublished - Jul 1 2005


  • Buprenorphine
  • Infants
  • Methadone
  • NAS
  • Opioids
  • Prenatal
  • Women

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)


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