Weekly long-acting buprenorphine improves treatment adherence and maintains maternal–neonatal safety outcomes in pregnant individuals with opioid use disorder
Written by: A. Dillikumari, BPharm
Reviewed By: Pharmacally Editorial Team
A randomized clinical trial supported by the National Institutes of Health found that weekly injectable extended-release buprenorphine improved illicit opioid abstinence rates in pregnant individuals with opioid use disorder (OUD), compared with standard daily sublingual buprenorphine. The findings were published in JAMA Internal Medicine.
The investigational approach uses a long-acting, subcutaneous formulation of buprenorphine administered weekly during pregnancy, with an option to switch to monthly dosing postpartum for individuals who are not breastfeeding. This strategy aims to address adherence challenges and stabilize drug exposure levels.
In the multicenter trial (NCT03918850), 140 pregnant adults were randomized to receive either extended-release injectable buprenorphine or standard sublingual buprenorphine, with or without naloxone. The study was conducted through the National Institute on Drug Abuse Clinical Trials Network under the NIH HEAL Initiative.
Results showed that participants receiving the extended-release formulation had significantly higher rates of illicit opioid abstinence during pregnancy, as measured by urine drug screening. Postpartum outcomes were non-inferior compared with the sublingual group.
Safety outcomes were generally comparable between groups. Non-serious maternal adverse events occurred at similar rates, although they were more frequently considered medication-related in the extended-release group during pregnancy. Importantly, serious maternal adverse events were less common with the injectable formulation. Rates of neonatal opioid withdrawal syndrome (NOWS) did not differ between treatment groups.
Buprenorphine is an established treatment for OUD during pregnancy. However, daily sublingual dosing can be associated with risks such as poor adherence, misuse, and fluctuating blood levels that may not adequately control cravings or withdrawal symptoms. The extended-release formulation provides more consistent drug exposure and reduces the need for daily dosing.
According to NIH leadership, the findings demonstrate that the injectable extended-release formulation is safe for use during pregnancy and improves abstinence outcomes compared with standard care, addressing an urgent need amid the ongoing opioid crisis. Investigators also noted that this is the first completed randomized trial evaluating extended-release buprenorphine in pregnant and postpartum populations, supporting its potential for immediate clinical application.
References
Clinical trial results support use of weekly extended-release buprenorphine for treatment of opioid use disorder during pregnancy, 16 March 2026 , https://www.nih.gov/news-events/news-releases/clinical-trial-results-support-use-weekly-extended-release-buprenorphine-treatment-opioid-use-disorder-during-pregnancy
Winhusen TJ, Lofwall MR, Kropp F, et al. Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial. JAMA Intern Med. Published online March 16, 2026. https://doi.org/10.1001/jamainternmed.2026.0057
Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs), ClinicalTrials.gov ID NCT03918850, https://clinicaltrials.gov/study/NCT03918850
About the Writer
Dilli Kumari is a Pharmacy graduate based in Ariyur, Puducherry. She has a strong interest in pharmacovigilance and is particularly drawn to data analysis within the healthcare field. She is known for her willingness to learn and continuously improve, with a keen attention to detail that sometimes leads her to spend extra time refining her work.