Buprenorphine for Opioid Addiction during Pregnancy

(MOMs Trial)

Recruiting at 11 trial locations

Overseen By Ben Kropp, MSLS

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: T. John Winhusen, PhD

Must be taking: Buprenorphine

Must not be taking: Methadone, Naltrexone

Disqualifiers: Alcohol dependence, Severe mental disorder, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

Trial Summary

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).

Research Team

T. John Winhusen, PhD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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.

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.

Treatment Details

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.

Participant Groups

Group I: BUP-XR Experimental Treatment 1 Intervention

Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).

Group II: BUP-SL Active Control 1 Intervention

Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).

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

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

Trials

2,658

Recruited

3,409,000+