Medication Treatment for Opioid-dependent Expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Two Buprenorphine Formulations (NIH HEAL Initiative)

Funded by the NIH HEAL Initiative^®

The growing opioid-use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations.  Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles.  Extended release (XR) formulations may address some of these disadvantages.  The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women with BUP-XR, compared to BUP-SL, on maternal-infant outcomes.  Testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL, is a secondary trial objective.