This editorial discusses a randomized trial comparing weekly extended-release with sublingual buprenorphine among 140 pregnant patients with opioid use disorder. It highlights favorable treatment engagement and infant outcomes in both groups and argues that pregnant and postpartum patients should be included in rigorous medication research rather than excluded because of pregnancy. The article interprets trial findings and ethical implications; it is not itself a clinical trial.
Pregnant and parenting people are among the groups most negatively impacted by the opioid crisis, yet they are last in line for rigorous medication research to improve outcomes. Overdose continues to be a leading cause of maternal deaths in the United States, and substance use is the primary reason infants are separated from their parents.1
In this issue of JAMA Internal Medicine, an important study by Winhusen et al2 indicates a shifting paradigm. The authors conducted a multicenter randomized clinical trial comparing sublingual buprenorphine vs weekly extended-release buprenorphine among 140 pregnant people with opioid use disorder (OUD).2 In both groups, more than 70% of participants had illicit opioid–negative drug tests at birth, and less than 30% of infants required pharmacologic treatment for neonatal abstinence syndrome. Serious adverse events were rare and, aside from one, not medication related. A notable strength of the study was observation through the entire 12-month postpartum period; two-thirds of participants remained adherent with medication at the end of the trial. These critical data provide clear support for including weekly extended-release buprenorphine alongside sublingual buprenorphine and methadone within the standard of care for perinatal patients. In short, to our knowledge, this marks the first randomized clinical trial of medications for OUD (MOUD) in pregnancy since the MOTHER Study reported in 2010.3
