Trial results support weekly buprenorphine treatment of opioid use disorder during pregnancy
NIH-supported, UC-led research published in JAMA Internal Medicine
In a clinical trial supported by the National Institutes of Health (NIH), a research team led by the University of Cincinnati found that administering weekly injectable extended-release buprenorphine for treatment of opioid use disorder (OUD) during pregnancy led to higher rates of abstinence from illicit opioids than buprenorphine given daily under the tongue (sublingual), one of the standard methods of treatment.
Additionally, serious adverse events were less common in those receiving extended-release treatment. The findings, which support the use of this formulation of buprenorphine for treating OUD during pregnancy, were published in JAMA Internal Medicine March 16.
“These findings are clinically valuable, for they show us that this injectable extended-release buprenorphine formulation is safe to use in pregnancy and results in better opioid abstinence outcomes compared to sublingual buprenorphine,” said Nora D. Volkow, MD, director of NIH’s National Institute on Drug Abuse (NIDA). “This is especially relevant in the context of the ongoing opioid overdose crisis and public health emergency.”
T. John Winhusen, PhD.
Illicit opioid use and untreated OUD can have dire consequences during pregnancy, including risk of fatal overdose for the mother and the development of neonatal opioid withdrawal syndrome (NOWS) and other adverse consequences for the baby.
Treating OUD in pregnancy with sublingual buprenorphine is effective, but it has disadvantages, including risk of misuse, potentially poor adherence and daily fluctuating blood levels known as peak-trough effects that may inadequately mitigate 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), extended-release buprenorphine injections during pregnancy — with the option of a monthly formulation for postpartum participants who were not breastfeeding — might promote as good or better opioid abstinence rates and NOWS outcomes.
In the multicenter trial, 140 pregnant adults were randomized to receive either injectable extended-release 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 testing 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 screens, were significantly higher for those receiving weekly extended-release buprenorphine and were non-inferior postpartum compared to participants receiving sublingual buprenorphine.
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While the percentage of participants experiencing non-serious maternal adverse events did not differ between the types of treatments, they were more commonly rated as medication-related in the extended-release group during pregnancy. Serious maternal adverse events were less common in the extended-release group throughout the trial. NOWS outcomes did not differ between the treatment groups.
“We knew that injectable extended-release buprenorphine leads to superior rates of illicit opioid abstinence in non-pregnant adults, but there had been no completed randomized clinical trial testing its use during pregnancy,” said principal investigator and lead author T. John Winhusen, PhD, principal investigator and lead author, director of the UC /UC Health Addiction Center, Donald C. Harrison endowed chair in medicine, vice chair of addiction sciences and professor in the Department of Psychiatry and Behavioral Neuroscience in UC’s College of Medicine. “It is exciting to share the results of this trial, which have immediate clinical application: this longer-acting medication can safely and more effectively support treatment and recovery in pregnant patients.”
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A version of this release was originally published by the National Institutes of Health.
Featured photo at top of a pregnant woman. Photo/Stock Planet/iStock.
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