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Multisite study focuses on opioid use during pregnancy

Dec. 5, 2019, 10:04 AM


by Kelsey Herbers

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.

Jessica Young, MD, MPH

“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 substudies will examine metabolism of both forms of the medication and long-term developmental outcomes for infants, examined at 12 and 24 months.

VUMC will enroll 24 of the project’s 300 total patients over the next four-and-a-half years. Women will be enrolled between six and 30 weeks of pregnancy and will continue to receive the medication for one year following delivery.

“The results of this study could change treatment options for pregnant women with opioid use disorder,” said Young.

“Having the opportunity to participate in a national trial of this magnitude is exciting and showcases the strong clinical work our program has put together in the past eight years since our launch. It’s also launching our program into research, and I’m excited about the potential that can bring for us and for patients.”

Led by Young, the Vanderbilt Maternal Addiction Recovery Program treats women with any type of substance use disorder during pregnancy. The program currently has more than 100 patients enrolled, many of whom travel long distances to the clinic located at One Hundred Oaks in Nashville.

The clinic aims to integrate prenatal, addiction and well-woman care by offering addiction treatment, peer support through group therapy, individual psychosocial support and education classes that teach both recovery and parenting skills.

Women typically stay with the program for at least one year following delivery, which is unique for an addiction program housed in an obstetrics department. Afterward, they’re often transitioned to the same psychiatrist they saw through the program, ensuring continuity of care.

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