Department of Pediatrics
Maternal Opioid Treatment:
Human Experimental Research (MOTHER)
The Maternal Opioid Treatment: Human Experimental Research (MOTHER) Project is an eight-site, international, double blind, double dummy, flexible-dosing, randomized controlled trial comparing the use buprenorphine and methadone in the context of comprehensive care in opioid dependent pregnant women. Participants were opioid dependent women between 18 to 41 years of age with a singleton pregnancy between 6 and 30 weeks gestation. Opioid dependence was determined by the E-Module of the Structured Clinical Interview for DSM-IV (SCID I) and a urine sample indicating current opioid use. Participants could not have a medical condition that contraindicated participation or a current diagnosis of benzodiazepine or alcohol abuse or dependence.
1074 pregnant women were screened for participation in the study; 243 declined participation; and 557 did not meet eligibility requirements. 175 were randomized to buprenorphine or methadone and 131 completed the study, i.e. participants who delivered while receiving double blind study medication. Eight sites provided screening data; seven sites contributed randomized data.
Please refer to the NEJM publication for a complete description of the study methods.