Medication Treatment for Opioid Use Disorder in Expectant Mothers
Status:
Recruiting
Trial end date:
2026-09-22
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the impact of treating opioid use disorder
(OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual
buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the
BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy
(non-inferiority).
Phase:
Phase 3
Details
Lead Sponsor:
T. John Winhusen, PhD Theresa Winhusen, PhD
Collaborators:
National Institute on Drug Abuse (NIDA) The Emmes Company, LLC The EMMES Corporation