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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
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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of illicit opioid-negative urine samples during pregnancy
Secondary outcome measures
Adequacy of Prenatal Care Utilization Index
Adjunct Medications
Ages and Stages Questionnaire, third edition (ASQ-3)
+13 moreTrial 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.).
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Who is running the clinical trial?
The Emmes Company, LLCIndustry Sponsor
146 Previous Clinical Trials
1,051,681 Total Patients Enrolled
T. John Winhusen, PhDLead Sponsor
3 Previous Clinical Trials
417 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,443 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with moderate/severe opioid use disorder and am a candidate for or currently on BUP treatment.I am not in, nor planning to join, high-intensity residential addiction treatment that restricts my movement.I plan to give birth in a hospital that follows specific protocols for newborn withdrawal syndrome.I am between 18 and 41 years old.I am pregnant, between 6-30 weeks along, and plan to continue my pregnancy.I am not currently on methadone or naltrexone for opioid use disorder.
Research Study Groups:
This trial has the following groups:- Group 1: BUP-XR
- Group 2: BUP-SL
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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