Buprenorphine for Opioid Addiction during Pregnancy

(MOMs-CMA 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

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

Duration: 12 months postpartum

97 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).

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 expectant mothers who are already participating in the MOMs trial and have opioid use disorder. It aims to understand how different forms of buprenorphine affect both mother and infant outcomes, including withdrawal symptoms in newborns.

Inclusion Criteria

Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either daily sublingual buprenorphine or weekly subcutaneous buprenorphine injection during pregnancy and postpartum

12 months postpartum

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of fetal heart rate variability and buprenorphine concentration in plasma

Estimated gestational age approximately 36 weeks to delivery

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine Injection
• Buprenorphine Sublingual Product

Trial Overview The study compares extended-release buprenorphine injections (BUP-XR) with sublingual products (BUP-SL), focusing on their effects on blood levels, fetal behavior, maternal adherence to medication, illicit opioid use, and infant development.

How Is the Trial Designed?

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+