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Medication Treatment for Opioid Use Disorder in Expectant Mothers
Sponsor: T. John Winhusen, PhD
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).
Official title: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations
Key Details
Gender
FEMALE
Age Range
18 Years - 41 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2020-07-21
Completion Date
2025-01-31
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.
Locations (12)
Gateway Community Services
Jacksonville, Florida, United States
Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of New Mexico Milagro Clinic
Albuquerque, New Mexico, United States
University of Cincinnati Health Perinatal Addictions Program
Cincinnati, Ohio, United States
CODA, Inc.
Portland, Oregon, United States
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah SUPeRAD Clinic
Salt Lake City, Utah, United States
Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington, United States
Marshall Health MARC Program
Huntington, West Virginia, United States