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COMPLETED
NCT03918850
PHASE3

Medication Treatment for Opioid Use Disorder in Expectant Mothers

Sponsor: T. John Winhusen, PhD

View on ClinicalTrials.gov

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

Interventions

DRUG

Buprenorphine Injection

Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).

DRUG

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