← Back to Search

Opioid Agonist

Buprenorphine for Opioid Addiction during Pregnancy (MOMs 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

Potential participants must meet Diagnostic and Statistical Manual (DSM)-5 criteria for moderate/severe OUD and be a good candidate for BUP maintenance and/or be currently prescribed BUP for the treatment of OUD

Potential participants must be 18-41 years of age

Must not have

Potential participants must not be currently receiving methadone or naltrexone for the treatment of OUD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months postpartum

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether an extended-release form of buprenorphine is as effective as the standard form in treating pregnant women with opioid use disorder, with the goal of improving outcomes for mother and child.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from buprenorphine treatments can include nausea, vomiting, constipation, headache, sweating, sleep problems and potential withdrawal symptoms if stopped abruptly.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with moderate/severe opioid use disorder and am a candidate for or currently on BUP treatment.

Select...

I am between 18 and 41 years old.

Select...

I am pregnant, between 6-30 weeks along, and plan to continue my pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not currently on methadone or naltrexone for opioid use disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months postpartum for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of illicit opioid-negative urine samples during pregnancy

Secondary study objectives

Adequacy of Prenatal Care Utilization Index

Adjunct Medications

Ages and Stages Questionnaire, third edition (ASQ-3)

+13 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 / 4Eligibility criteria met