This multisite study, the first trial to study BUP-XR in pregnant women, is led nationally by T. Winhusen, Ph.D., at the University of Cincinnati. In all, 200 participants will be randomized into the trial. Approximately 25 of those participants will be recruited locally at Marshall Health. Participants will be compensated for their time.
According to Winhusen, the growing opioid-use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant women with opioid use disorder and of infants experiencing neonatal opioid withdrawal syndrome, a condition associated with adverse health effects for the infant. The American College of Obstetricians and Gynecologists and the American Society of Addiction Medicine recommend that pregnant women with opioid use disorder be treated with a medication like BUP-SL. Winhusen notes that while BUP-SL can be very beneficial, there are some associated disadvantages including the need for daily self-administration, a daily peak-trough BUP cycle, and the potential for diversion. The investigational BUP-XR formulation is subcutaneously injected by a medical provider and releases buprenorphine steadily for an extended period of time. By comparing the BUP-XR formulation with BUP-SL, this study has the potential to expand available treatment options for pregnant women struggling with opioid use disorder.
The study team at Marshall Health, led by Zachary H. Hansen, M.D., assistant professor of family and community health at the Joan C. Edwards School of Medicine and medical director of Marshall Health’s Maternal Addiction Recovery Center (MARC), is seeking expectant mothers between the ages of 18 and 41 and who struggle with illicit opioid use. Study participants must be willing to attend treatment for opioid use disorder and be randomized to receive either BUP-XR or BUP-SL. For more information or to participate in the study, contact Lacey Andrews, study coordinator for the Marshall Health team, at 304-877-8266.