Weekly Buprenorphine Shows Superior Results for Pregnant Women with Opioid Use Disorder

Bethesda, Maryland — A National Institutes of Health-funded clinical trial has found that weekly injectable extended-release buprenorphine leads to higher rates of abstinence from illicit opioids among pregnant women with opioid use disorder compared to daily sublingual treatment, representing a significant advancement in maternal addiction care. The findings were reported by the National Institutes of Health, published in JAMA Internal Medicine, and involved researchers from the National Institute on Drug Abuse, the University of Cincinnati College of Medicine, and the NIH HEAL Initiative. Additional context on treating opioid use disorder during pregnancy was provided by the Substance Abuse and Mental Health Services Administration. Each of the bullet points immediately below have been confirmed by at least four of the six respected sources we curated on this story.

• The randomized multicenter trial enrolled 140 pregnant adults who were randomly assigned to receive either weekly injectable extended-release buprenorphine or daily sublingual buprenorphine, with or without naloxone.
• Rates of illicit opioid abstinence during pregnancy, as measured by urine drug screens, were significantly higher among participants receiving the weekly extended-release formulation compared to those receiving daily sublingual treatment.
• The extended-release formulation demonstrated non-inferior abstinence rates postpartum compared to sublingual treatment among participants who continued in the study.
• Serious maternal adverse events were less common throughout the trial among those receiving extended-release buprenorphine compared to the sublingual group.
• Neonatal opioid withdrawal syndrome outcomes did not differ significantly between the treatment groups, indicating comparable safety profiles for newborn health.
• The study represents the first randomized clinical trial testing extended-release buprenorphine specifically for opioid use disorder during pregnancy and through the postpartum period.

Additional Details Reported

Illicit opioid use and untreated opioid use disorder during pregnancy pose serious health risks, including fatal overdose for mothers and the development of neonatal opioid withdrawal syndrome for babies. While sublingual buprenorphine has been the standard of care, it carries disadvantages including potential misuse, adherence challenges, and daily fluctuating blood levels that may inadequately address cravings and withdrawal symptoms.

The extended-release formulation provides consistent medication levels throughout the week, potentially reducing the burden of daily dosing for pregnant patients managing addiction while preparing for childbirth. Lead researcher Dr. John Winhusen of the University of Cincinnati College of Medicine noted that the longer-acting medication can safely and more effectively support treatment and recovery in pregnant patients.

While non-serious maternal adverse events did not differ significantly between groups, those in the extended-release group during pregnancy more commonly rated events as medication-related. The study was conducted through the NIDA Clinical Trials Network as part of the NIH HEAL Initiative, a comprehensive federal effort addressing the nation’s opioid crisis.

Participants in the extended-release group had the option to transition to a monthly formulation postpartum if not breastfeeding, offering continued flexibility in treatment approaches. The findings have immediate clinical application and could influence treatment guidelines for pregnant patients with opioid use disorder.

The research was supported by NIH funding through the National Institute on Drug Abuse. Complete study results are available in the March 2026 issue of JAMA Internal Medicine. Individuals seeking help for opioid use disorder can visit FindTreatment.gov or call 800-662-HELP (4357) for support resources.

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