Buprenorphine for Opioid Addiction during Pregnancy
(MOMs Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
T. John Winhusen, PhD
Principal Investigator
University of Cincinnati
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 18-41 with opioid use disorder, carrying a single fetus between 6-30 weeks gestation. They must be in outpatient addiction treatment, understand English, and consent to the study. Exclusions include alcohol/sedative dependence needing detoxification, severe psychiatric conditions, certain medical issues like high liver enzymes or kidney dysfunction, incarceration or unstable circumstances.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either extended-release buprenorphine (BUP-XR) or daily sublingual buprenorphine (BUP-SL) during pregnancy
Postpartum Treatment
Participants continue receiving BUP-XR or BUP-SL for 12 months postpartum, with breastfeeding participants receiving weekly BUP-XR and non-breastfeeding participants receiving monthly BUP-XR
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Buprenorphine Injection
- Buprenorphine Sublingual Product
Find a Clinic Near You
Who Is Running the Clinical Trial?
T. John Winhusen, PhD
Lead Sponsor
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
National Institute on Drug Abuse (NIDA)
Collaborator