Extended-Release Buprenorphine Effective for Opioid Use Disorder in Pregnancy: JAMA

A recent study published in the Journal of the American Medical Association revealed that extended-release buprenorphine given as a weekly injection led to higher rates of illicit opioid abstinence in pregnant women with opioid use disorder (OUD) when compared to daily sublingual buprenorphine. The rates of neonatal opioid withdrawal syndrome (NOWS) and maternal adverse events were similar between the injectable and sublingual treatments, indicating comparable safety for both mothers and newborns. 

Treating OUD during pregnancy is critical for both maternal and infant health. Sublingual buprenorphine, taken daily under the tongue, is currently considered an evidence-based standard treatment. However, daily dosing can present challenges, including adherence issues, medication diversion risks, and the need for frequent clinic visits. 

This clinical trial from July 2020 to October 2024, enrolled 140 pregnant adults with OUD across 13 outpatient cross-disciplinary peripartum treatment sites. Participants were between 6 and 30 weeks pregnant at enrollment and were randomly assigned to receive either sublingual buprenorphine or an extended-release version administered weekly during pregnancy. After delivery, participants in the extended-release group had the option to switch to a monthly formulation if they were not breastfeeding.

This study primarily evaluated illicit opioid abstinence during pregnancy and the postpartum period. Abstinence was measured using weekly urine samples tested for illicit opioids. Secondary outcomes included infant health measures like the need for treatment of NOWS and the duration of such treatment.

The results showed elevated rates of illicit opioid abstinence during pregnancy among participants receiving extended-release buprenorphine. Approximately 82.5% of their weekly urine samples tested negative for illicit opioids when compared to 72.6% in the sublingual group, which represented a statistically significant improvement.

When compared to those taking sublingual buprenorphine, the participants receiving the long-acting medication experienced fewer serious adverse events during pregnancy and after delivery. While nonserious adverse events occurred at similar rates overall, medication-related side effects were reported more often among extended-release users during pregnancy.

About 30% of infants exposed to extended-release buprenorphine required opioid treatment for NOWS, similar to the 26.5% rate among infants exposed to sublingual buprenorphine. The average duration of treatment for withdrawal symptoms also did not significantly differ.

Infants exposed to the extended-release medication had slightly larger average head circumferences, though the clinical significance of this finding remains uncertain. Overall, the study supports weekly extended-release buprenorphine as an effective and safe treatment option for OUD during pregnancy.

Reference:

Winhusen, T. J., Lofwall, M. R., Kropp, F., Lewis, D., Smid, M. C., Young, J. L., Hodgkins, C., Krans, E. E., Hansen, Z., Wachman, E. M., Schiff, D. M., Guille, C., Rudolf, V., Chowdhury, T., Leeman, L., Lewis, M., Matthews, A. G., Cochran, G., King, J., … Rosa, C. (2026). Extended-release vs sublingual buprenorphine in pregnancy through 12 months post partum: A randomized clinical trial. JAMA Internal Medicine. https://doi.org/10.1001/jamainternmed.2026.0057