Clinical Trials Directory

Trials / Completed

CompletedNCT03918850

Medication Treatment for Opioid Use Disorder in Expectant Mothers

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
140 (actual)
Sponsor
T. John Winhusen, PhD · Academic / Other
Sex
Female
Age
18 Years – 41 Years
Healthy volunteers
Not accepted

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).

Detailed description

This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether they are on BUP-SL at the time of randomization (yes vs. no). Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum.

Conditions

Interventions

TypeNameDescription
DRUGBuprenorphine InjectionWeekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
DRUGBuprenorphine Sublingual ProductSublingual buprenorphine (BUP-SL), administered daily.

Timeline

Start date
2020-07-21
Primary completion
2025-01-31
Completion
2025-01-31
First posted
2019-04-18
Last updated
2025-06-27

Locations

12 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03918850. Inclusion in this directory is not an endorsement.