Substance use disorder is a leading cause of pregnancy-related and pregnancy-associated death in Tennessee.
Vanderbilt Health continues to be on the forefront of addressing the increasing toll of the opioid crisis on pregnant and postpartum women and their infants.
It is among 13 sites in the United States to evaluate the use of sublingual buprenorphine, the evidence-based standard of care, versus an injectable, extended-release formulation of the medication in the treatment of pregnant women with opioid use disorder.
JAMA Internal Medicine published the findings of the trial, “Medication treatment for opioid use disorder in expectant mothers (MOMs),” which was funded by the National Institute on Drug Abuse, part of the National Institutes of Health.
“The extended-release formulation is an effective treatment for this patient population and it’s safe for their babies,” said Jessica Young, MD, MPH, study co-author and principal site investigator at Vanderbilt Health.
“We now have one more treatment option,” said Young, associate professor of Clinical Obstetrics and Gynecology at Vanderbilt Health and medical director of Firefly, a comprehensive care and treatment program for pregnant and postpartum women with substance use disorder and their children. “I was a bit surprised at the data — just how much the relapse and adverse events improved. It was a big difference.”
In the study, women were randomized to either receive the standard treatment, a daily sublingual dose of buprenorphine, which has disadvantages including multiple daily doses, risk of misuse, poor adherence, fluctuating levels that can negatively impact opioid cravings and withdrawals, or to receive a weekly extended-release buprenorphine injection that is a long-acting, continuous release formulation that negates the highs and lows experienced with oral medications.
“We found that patients had a much better experience with fewer cravings and withdrawal symptoms because the injected dose is long acting,” said Young. “Patients had a bit more flexibility with timing of the next dose, which is important with required clinic visits for medication administration.”
Postpartum patients who were not breastfeeding had the option in the study of moving to a monthly formulation of buprenorphine injection to maintain abstinence.
Study findings state:
- Pregnant women randomized to extended-release buprenorphine had higher rates of illicit opioid abstinence and fewer adverse events than those randomized to sublingual buprenorphine.
- Neonatal opioid withdrawal syndrome outcomes did not differ between the weekly injectable treatment and the daily sublingual treatment.
- Previous trials had not established safety and efficacy of extended-release buprenorphine in pregnancy and postpartum, and this reflects a broader issue of not including pregnant women in research, according to outside experts.
Young, whose program serves women in 26 counties in Tennessee, is very hopeful that the newest treatment option “will have a significant impact as it has the potential to improve outcomes, relapse rates and adverse events during pregnancy.”
This work was supported by the National Institute on Drug Abuse under award numbers UG1DA013732, UG1DA015831, UG1DA015815, UG1DA013720, UG1DA013727, UG1DA049436, UG1DA013714, UG1DA049468 and UG1DA049444.
