Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: effects on the neonatal abstinence syndrome.
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.
Jones
Hendree E
HE
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
Johnson
Rolley E
RE
Jasinski
Donald R
DR
O'Grady
Kevin E
KE
Chisholm
Christian A
CA
Choo
Robin E
RE
Crocetti
Michael
M
Dudas
Robert
R
Harrow
Cheryl
C
Huestis
Marilyn A
MA
Jansson
Lauren M
LM
Lantz
Michael
M
Lester
Barry M
BM
Milio
Lorraine
L
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
D009292:Narcotic Antagonists; D002047:Buprenorphine; D008691:Methadone