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Completed Phase 3 Interventional Results available

Medication Treatment for Opioid Use Disorder in Expectant Mothers

ClinicalTrials.gov ID: NCT03918850

Public ClinicalTrials.gov record NCT03918850. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 11:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03918850
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
T. John Winhusen, PhD
Other
Enrollment
140 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 41 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 21, 2020 (Actual)
Primary completion
Jan 31, 2025 (Actual)
Completion
Jan 31, 2025 (Actual)
Last update posted
Jun 4, 2026

2020 – 2025

United States locations

U.S. sites
12
U.S. states
11
U.S. cities
11
Facility City State ZIP Site status
Gateway Community Services Jacksonville Florida 32204 —
Massachusetts General Hospital HOPE Clinic Boston Massachusetts 02114 —
Boston Medical Center Boston Massachusetts 02118 —
University of New Mexico Milagro Clinic Albuquerque New Mexico 87106 —
University of Cincinnati Health Perinatal Addictions Program Cincinnati Ohio 45229 —
CODA, Inc. Portland Oregon 97214 —
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania 15213 —
Medical University of South Carolina Charleston South Carolina 29425 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
University of Utah SUPeRAD Clinic Salt Lake City Utah 84108 —
Addiction Recovery Services (ARS), Swedish Medical Center Seattle Washington 98107 —
Marshall Health MARC Program Huntington West Virginia 25701 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03918850, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 4, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03918850 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →