Peer ReviewedPublished: 2026Publication: JAMA Internal Medicine.

Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial

Marcela Smid; Davida Schiff; Vania Rudolf
JAMA Internal Medicine.

Research Summary

In a randomized clinical trial involving 140 pregnant adults with opioid use disorder, weekly injectable extended-release buprenorphine was compared with sublingual buprenorphine through pregnancy and 12 months postpartum. The extended-release group had statistically higher illicit-opioid abstinence, while neonatal opioid withdrawal outcomes did not differ significantly. Medication-related maternal adverse events were reported more often during pregnancy in the extended-release group, but serious adverse events were less common across the full trial. These findings support extended-release buprenorphine as a treatment option while requiring individualized clinical assessment.


Key Points

Question  Does weekly subcutaneous extended-release buprenorphine treatment for opioid use disorder (OUD) in pregnancy produce noninferior illicit opioid abstinence rates and superior neonatal opioid withdrawal syndrome (NOWS) outcomes vs sublingual buprenorphine?

Findings  In this randomized clinical trial with 140 pregnant adults, illicit-opioid abstinence in the extended-release group was statistically superior to that in the sublingual group. NOWS outcomes and maternal adverse events (AEs) did not differ between treatments, although the latter were more commonly rated as medication-related in the extended-release group during pregnancy; however, maternal serious AEs were less common in the extended-release group throughout the trial.

Meaning  These findings support using weekly extended-release buprenorphine for OUD during pregnancy.