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: 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
• Journal: Drug and alcohol dependence (Drug Alcohol Depend) Vol. 79 Issue 1 Pg. 1-10 (Jul 2005) ISSN: 0376-8716 [Print] Ireland
• PMID: 15943939 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Narcotic Antagonists
• Buprenorphine
• Methadone

Topics

• Administration, Sublingual
• Adult
• Buprenorphine (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Heroin Dependence (rehabilitation)
• Humans
• Infant, Newborn
• Methadone (adverse effects, therapeutic use)
• Narcotic Antagonists (adverse effects, therapeutic use)
• Neonatal Abstinence Syndrome (diagnosis, etiology)
• Pregnancy
• Pregnancy Complications
• Severity of Illness Index