ORN Fall 2026 - A Randomized Trial of Extended-release Buprenorphine for Opioid Use Disorder Treatment During Pregnancy and for 12-months Postpartum: Results from National Institute on Drug Abuse Clinical Trials Network Study 0080-2026-09-16

Video Transcription

Video Summary

The webinar featured Dr. Michelle Loffall discussing results from the MOMS trial, a randomized, open-label non-inferiority study comparing weekly extended-release buprenorphine (BUP-XR) with sublingual buprenorphine (BUP-SL) for opioid use disorder during pregnancy and up to 12 months postpartum. Conducted at 13 sites across 12 states, the trial enrolled 140 pregnant participants, most of whom were already stabilized on sublingual buprenorphine.<br /><br />The main finding was that BUP-XR was non-inferior and then superior to BUP-SL for illicit opioid-negative urine tests during pregnancy, with about a 10% absolute difference. This advantage disappeared postpartum. Adherence to buprenorphine was similarly high in both groups, suggesting the benefit may relate to the pharmacokinetic stability of the injectable formulation.<br /><br />Infant outcomes were broadly similar between groups, including need for NOWS treatment, hospital stay, and developmental screening at 12 months. Safety outcomes were also reassuring overall, though serious adverse events were more common in the sublingual group, while medication-related adverse events were more often attributed to XR. A small increase in head circumference with XR was statistically significant but still within normal ranges.<br /><br />Overall, the trial supports weekly extended-release buprenorphine as a useful treatment option in pregnancy and postpartum, with no major safety concerns identified.

Keywords

MOMS trial

extended-release buprenorphine

sublingual buprenorphine

opioid use disorder

pregnancy

postpartum

non-inferiority study

NOWS treatment

pharmacokinetic stability