title: Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: effects on the neonatal abstinence syndrome.
abstract: 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.
authors.affiliation: The Department of Psychiatry and Behavioral Sciences, Johns Hopkins Bayview Medical Campus, Johns Hopkins University School of Medicine, D-3-East, 4940 Eastern Avenue, Baltimore, MD 21224, USA. hejones@jhmi.edu
authors.forename: Hendree E
authors.initials: HE
authors.lastname: Jones
authors.forename: Rolley E
authors.initials: RE
authors.lastname: Johnson
authors.forename: Donald R
authors.initials: DR
authors.lastname: Jasinski
authors.forename: Kevin E
authors.initials: KE
authors.lastname: O'Grady
authors.forename: Christian A
authors.initials: CA
authors.lastname: Chisholm
authors.forename: Robin E
authors.initials: RE
authors.lastname: Choo
authors.forename: Michael
authors.initials: M
authors.lastname: Crocetti
authors.forename: Robert
authors.initials: R
authors.lastname: Dudas
authors.forename: Cheryl
authors.initials: C
authors.lastname: Harrow
authors.forename: Marilyn A
authors.initials: MA
authors.lastname: Huestis
authors.forename: Lauren M
authors.initials: LM
authors.lastname: Jansson
authors.forename: Michael
authors.initials: M
authors.lastname: Lantz
authors.forename: Barry M
authors.initials: BM
authors.lastname: Lester
authors.forename: Lorraine
authors.initials: L
authors.lastname: Milio
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D002047:Buprenorphine / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006556:Heroin Dependence / Q000534:rehabilitation*; D006801:Humans; D007231:Infant, Newborn; D008691:Methadone / Q000009:adverse effects* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D009357:Neonatal Abstinence Syndrome / Q000175:diagnosis* / Q000209:etiology*; D011247:Pregnancy; D011248:Pregnancy Complications; D012720:Severity of Illness Index
chemical_list: D009292:Narcotic Antagonists; D002047:Buprenorphine; D008691:Methadone