Buprenorphine for Opioid Addiction during Pregnancy (MOMs-CMA Trial)

Phase 3

Waitlist Available

Research Sponsored by T. John Winhusen, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks post-randomization

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare blood levels and outcomes of expectant mothers taking either extended-release buprenorphine or sublingual buprenorphine to treat their opioid use disorder.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions to buprenorphine such as nausea, vomiting, constipation, muscle aches or cramps. There might also be an impact on fetal heart rate variability and potential withdrawal symptoms in infants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated gestational age (ega) approximately 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~estimated gestational age (ega) approximately 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated gestational age (ega) approximately 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cmax of buprenorphine and metabolites in plasma

Cmin of buprenorphine and metabolites in plasma

Buprenorphine

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BUP-XRExperimental Treatment1 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-SLActive Control1 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.).

0 / 1Eligibility criteria met