← 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 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.).

Find a Location

Who is running the clinical trial?

The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,051,998 Total Patients Enrolled
2 Trials studying Neonatal Abstinence Syndrome
297 Patients Enrolled for Neonatal Abstinence Syndrome
T. John Winhusen, PhDLead Sponsor
4 Previous Clinical Trials
738 Total Patients Enrolled
2 Trials studying Neonatal Abstinence Syndrome
297 Patients Enrolled for Neonatal Abstinence Syndrome
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,795 Total Patients Enrolled
13 Trials studying Neonatal Abstinence Syndrome
1,158 Patients Enrolled for Neonatal Abstinence Syndrome

Media Library

Buprenorphine Injection (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03918850 — Phase 3
Neonatal Abstinence Syndrome Research Study Groups: BUP-XR, BUP-SL
Neonatal Abstinence Syndrome Clinical Trial 2023: Buprenorphine Injection Highlights & Side Effects. Trial Name: NCT03918850 — Phase 3
Buprenorphine Injection (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03918850 — Phase 3
~3 spots leftby Jan 2025