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

• Published in: Drug and alcohol dependence Vol. 79; no. 1; pp. 1 - 10
• Main Authors: Jones, Hendree E., Johnson, Rolley E., Jasinski, Donald R., O’Grady, Kevin E., Chisholm, Christian A., Choo, Robin E., Crocetti, Michael, Dudas, Robert, Harrow, Cheryl, Huestis, Marilyn A., Jansson, Lauren M., Lantz, Michael, Lester, Barry M., Milio, Lorraine
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 01.07.2005; Elsevier Science
• Subjects: Addictive behaviors; Administration, Sublingual; Adult; Adult and adolescent clinical studies; Biological and medical sciences; Buprenorphine; Buprenorphine - adverse effects; Buprenorphine - therapeutic use; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Heroin Dependence - rehabilitation; Humans; Infant, Newborn; Infants; Medical sciences; Methadone; Methadone - adverse effects; Methadone - therapeutic use; Narcotic Antagonists - adverse effects; Narcotic Antagonists - therapeutic use; NAS; Neonatal abstinence syndrome; Neonatal Abstinence Syndrome - diagnosis; Neonatal Abstinence Syndrome - etiology; Opioids; Pregnancy; Pregnancy Complications; Pregnant women; Prenatal; Psychoanalysis; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Severity of Illness Index; Women; Women; Prenatal; NAS; Buprenorphine; Opioids; Infants; Methadone; Neonatal; Replacement therapy; Psychology; Infant; Opiates; Narcotic analgesic; Adult; Female; Woman; Human; Drug addiction; Poison withdrawal; Abstinence; Syndrome; Pregnancy; Newborn; Addiction; Psychiatry; Comparative study
• ISSN: 0376-8716; 1879-0046
• DOI: 10.1016/j.drugalcdep.2004.11.013

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.