In a clinical trial supported by the National Institutes of Health (NIH), a research team found that weekly injectable extended-release buprenorphine for the treatment of opioid use disorder (OUD) during pregnancy resulted in higher rates of abstinence from illicit opioids than buprenorphine administered daily under the tongue (sublingually). In addition, serious side effects were less common in those who received extended-release therapy. The findings, which support the use of this buprenorphine formulation to treat OUD during pregnancy, were published in JAMA Internal Medicine.
These findings are clinically valuable because they show us that this injectable formulation of sustained-release buprenorphine is safe for use in pregnancy and leads to 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. Volkow, MD, director of NIH’s National Institute on Drug Abuse (NIDA)
Illicit opioid use and untreated OUD can have devastating consequences during pregnancy, including the risk of fatal overdose for the mother and the development of neonatal opioid withdrawal syndrome (NOWS) and other adverse outcomes for the baby. Treatment of OUD in pregnancy with sublingual buprenorphine is effective but has drawbacks, including risk of misuse, potentially poor adherence, and daily fluctuating blood levels known as peaks that may inadequately moderate opioid-related cravings and withdrawal, leading to continued opioid use. The researchers in this study wanted to see if using a weekly formulation of subcutaneous (under the skin), buprenorphine extended-release injections during pregnancy—with the option of a monthly formulation for postpartum participants who were not breastfeeding—could promote opioid abstinence rates as well or better than NOWS outcomes.
In the multicenter trial, 140 pregnant adults were randomized to receive either injectable extended-release buprenorphine or sublingual buprenorphine (with or without naloxone). The trial, supported by the NIDA Clinical Trials Network as part of the NIH Helping to End Addiction Long-term ® Initiative (NIH HEAL Initiative®), was the first randomized trial of extended-release buprenorphine for OUD in pregnancy and postpartum.
The researchers found that rates of illicit opioid abstinence during pregnancy, as measured by urine drug tests, were significantly higher for those receiving weekly extended-release buprenorphine and were not inferior postpartum compared to participants receiving sublingual buprenorphine. While the proportion of participants who experienced non-serious maternal adverse events did not differ between treatment types, they were more often rated as drug-related in the extended-release group during pregnancy. Serious maternal adverse events were less frequent in the extended-release group throughout the trial. NOWS scores did not differ between treatment groups.
“We knew that injectable extended-release buprenorphine leads to higher rates of illicit opioid abstinence in non-pregnant adults, but no randomized clinical trial testing its use during pregnancy had been completed,” said principal investigator and lead author John Winhusen, Ph.D., professor of psychiatry and behavioral medicine at the University of Mediciinine in Neevicinati. “It is exciting to share the results of this trial, which have immediate clinical application: this longer-acting drug can safely and more effectively support treatment and recovery in pregnant patients.”
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