CTN-0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): A Pragmatic Randomized Trial Comparing Two Buprenorphine Formulations (NIH HEAL Initiative)

T. John Winhusen, PhD
Lead Investigator
University of Cincinnati
Addiction Sciences Division
winhust@ucmail.uc.edu

The growing opioid-use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL, is a secondary trial objective. Funded by the NIH HEAL Initiative^SM.

New from CTN-0080: Prenatal Action for Taking Health Steps (PATHS) Toolkit

The Prenatal Action for Taking Health Steps (PATHS) Toolkit was developed by this protocol team and includes flyers, info sheets, posters, an education video, and social media images and short videos (“Reels”), all available for download and sharing. The toolkit is available in a version for the general public, a version culturally adapted for American Indian and Alaska Native communities, and a version translated into Spanish (coming soon!).

Related Studies

Primary Findings

Among 140 randomized participants, all but 2 were already prescribed sublingual buprenorphine. Illicit opioid abstinence was higher during pregnancy for participants receiving extended-release vs sublingual buprenorphine (82.5% vs 72.6%). Postpartum abstinence rates declined and were similar in both groups (60.2% vs 59.5%). Those receiving extended-release buprenorphine experienced fewer serious adverse events during pregnancy (8.7% vs 26.8%) and post partum (6.0% vs 18.6%). Nonserious adverse events rates did not differ between groups, but more were deemed medication-related for extended-release participants during pregnancy (26.1% vs 7.0%). Infants exposed to extended-release vs sublingual buprenorphine did not differ in need for opioid treatment (30.2% vs 26.5%). The findings of this randomized clinical trial support weekly extended-release buprenorphine for OUD treatment during pregnancy.