140 Participants Needed

Buprenorphine for Opioid Addiction during Pregnancy

(MOMs Trial)

Recruiting at 11 trial locations
FK
BK
Overseen ByBen Kropp, MSLS
Age: 18 - 65
Sex: Female
Trial Phase: Phase 3
Sponsor: T. John Winhusen, PhD
Must be taking: Buprenorphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

TJ

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

Potential participants must have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable)
Potential participants must be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake)
I have been diagnosed with moderate/severe opioid use disorder and am a candidate for or currently on BUP treatment.
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Exclusion Criteria

Potential participants must not have a physiological dependence on alcohol or sedatives requiring medical detoxification
Potential participants must not have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include: Suicidal or homicidal ideation requiring immediate attention, Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)
Potential participants must not be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either extended-release buprenorphine (BUP-XR) or daily sublingual buprenorphine (BUP-SL) during pregnancy

Screening through delivery
Weekly visits

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

12 months
Weekly or monthly visits depending on breastfeeding status

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

  • Buprenorphine Injection
  • Buprenorphine Sublingual Product
Trial Overview The study compares two forms of buprenorphine: extended-release injection (BUP-XR) versus sublingual product (BUP-SL), assessing their impact on both mother and infant outcomes during pregnancy. The goal is to see if BUP-XR is at least as effective as BUP-SL without increasing illicit opioid use.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: BUP-XRExperimental Treatment1 Intervention
Group II: BUP-SLActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

T. John Winhusen, PhD

Lead Sponsor

Trials
5
Recruited
750+

The Emmes Company, LLC

Industry Sponsor

Trials
149
Recruited
1,052,000+
Peter Ronco profile image

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman profile image

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

Trials
2,658
Recruited
3,409,000+
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