The Vanderbilt Maternal Addiction Recovery Program is participating in a 12-site clinical trial that will compare two forms of the medication buprenorphine in treating opioid use disorder during pregnancy, and the results could have a potentially significant impact on clinical practice.
The study, funded by the National Institute on Drug Abuse, will randomize participants to either buprenorphine tablets, which dissolve under the tongue, or extended release buprenorphine, which is injected under the skin.
Currently, sublingual buprenorphine and methadone tablets are the two medications considered standard of care for opioid use disorder during pregnancy. Extended release buprenorphine has never been studied in pregnancy but is hypothesized to improve outcomes for both the mother and baby.
“The thought is that because the extended release buprenorphine is long-acting, it will maintain steady states of the medication, which will decrease cravings and relapses,” said Jessica Young, MD, MPH, associate professor in Vanderbilt University Medical Center’s Department of Obstetrics and Gynecology and the principal investigator for Vanderbilt’s portion of the study.
The medication level declines at a slower rate when it’s injected as opposed to the abrupt decline that occurs when a tablet wears off.
Having the medication injected weekly in clinic means patients don’t have to remember to take a daily medication, likely increasing adherence to treatment. Since there’s no medication for patients to store at home, the injections also prevent the risk of drug diversion.
The study will look at relapse rates and infant outcomes — such as occurrences of neonatal abstinence syndrome and hospitalizations — as its primary outcomes. Two sub-studies will examine metabolism of both forms of the medication and long-term develop-
mental outcomes for infants, examined at 12 and 24 months.
“The results of this study could change treatment options for pregnant women with opioid use disorder,” said Young.