In a clinical trial supported by the National Institutes of Health (NIH), researchers found that weekly injections of extended-release buprenorphine to treat opioid use disorder (OUD) during pregnancy resulted in higher rates of abstinence from illicit opioids than daily sublingual (sublingual) administration of buprenorphine, one of the standard treatments. Additionally, serious adverse events were less common in patients receiving extended-release therapy. Research findings support the use of this formulation of buprenorphine in the treatment of OUD during pregnancy. JAMA Internal Medicine.
These findings are clinically valuable as they demonstrate that this injectable extended-release buprenorphine formulation can be safely used during pregnancy and provides better opioid abstinence outcomes compared to sublingual buprenorphine. This is especially important in the context of the ongoing opioid overdose crisis and public health emergency. ”
Nora D. Borkow, MD, Director, NIH National Institute on Drug Abuse (NIDA)
Illegal opioid use and untreated OUD can have devastating consequences during pregnancy, including the risk of fatal overdose for the mother, the development of neonatal opioid withdrawal syndrome (NOWS), and other negative effects on the baby. Treating OUD during pregnancy with sublingual buprenorphine is effective, but has drawbacks, including the risk of misuse, potential for decreased adherence, and diurnal fluctuations in blood concentrations known as the peak-trough effect, which can lead to insufficient relief of opioid-related craving and withdrawal symptoms and lead to continued opioid use. The study’s researchers wanted to determine whether using a weekly subcutaneous (subcutaneous) extended-release buprenorphine injection formulation during pregnancy (with the option of a monthly formulation for postpartum participants who were not breastfeeding) would equally or more promote opioid abstinence rates and NOWS outcomes.
In a multicenter trial, 140 pregnant women were randomly assigned to receive extended-release buprenorphine injections or sublingual buprenorphine (with or without naloxone). This study, supported by the NIDA Clinical Trials Network as part of the NIH HEAL Initiative®, was the first randomized trial to test extended-release buprenorphine for OUD during pregnancy and postpartum.
The researchers found that illicit opioid abstinence rates during pregnancy, as measured by urine drug screening, were significantly higher in participants receiving weekly extended-release buprenorphine and were noninferior postpartum compared with participants receiving sublingual buprenorphine. The proportion of participants who experienced non-serious maternal adverse events did not differ between treatment types, but they were more commonly assessed as drug-related in the extended-release group during pregnancy. Serious maternal adverse events were less common in the extended-release group during the study period. NOWS results did not differ between treatment groups.
“While we knew that extended-release injectable buprenorphine had superior rates of illicit opioid abstinence in non-pregnant adults, no randomized clinical trials had been completed to test its use during pregnancy,” said principal investigator and lead author John Winhusen, Ph.D., professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine. “We are very pleased to share the results of this study, which have immediate clinical application. This long-acting drug can safely and more effectively support the treatment and recovery of pregnant patients.”
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