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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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months postpartum
Awards & highlights

MOMs 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.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.

MOMs Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with moderate/severe opioid use disorder and am a candidate for or currently on BUP treatment.
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I have been diagnosed with moderate/severe opioid use disorder and am a candidate for or currently on BUP treatment.
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I am between 18 and 41 years old.
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I am pregnant, between 6-30 weeks along, and plan to continue my pregnancy.
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I plan to give birth in a hospital that follows specific care protocols for newborn withdrawal syndrome.
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I am pregnant, between 6-30 weeks, and plan to continue my pregnancy.
Select...
I am between 18 and 41 years old.

MOMs Trial 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

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 more

MOMs 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
145 Previous Clinical Trials
1,051,351 Total Patients Enrolled
2 Trials studying Substance Abuse
297 Patients Enrolled for Substance Abuse
T. John Winhusen, PhDLead Sponsor
3 Previous Clinical Trials
417 Total Patients Enrolled
3 Trials studying Substance Abuse
417 Patients Enrolled for Substance Abuse
National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,856 Total Patients Enrolled
152 Trials studying Substance Abuse
707,002 Patients Enrolled for Substance Abuse

Media Library

Buprenorphine Injection (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03918850 — Phase 3
Substance Abuse Research Study Groups: BUP-XR, BUP-SL
Substance Abuse 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research allow for participants that are above a certain age?

"The age parameters for this trial are much narrower than others, as only patients between 18-41 years old can enroll. In contrast, 515 clinical trials allow people under the age of 18 to participate while 1584 extend to those over 65."

Answered by AI

Who qualifies to participate in this research?

"This particular clinical trial is testing an experimental medication for treating opioid abuse in adults aged 18-41. They are looking for around 200 participants in total."

Answered by AI

Are there any available openings for new participants in this clinical trial?

"Yes, this is an ongoing clinical trial that is currently recruiting patients. According to the listing on clinicaltrials.gov, the trial was posted on July 21st, 2020 and last updated on November 11th, 2020."

Answered by AI

How many people can enroll in this research project?

"In order to successfully complete this clinical trial, 200 patients who meet the specified inclusion criteria must be recruited. These potential participants can come from different locations such as Pregnancy Recovery Center at Magee-Womens Hospital of UPMC in Pittsburgh, Pennsylvania and Gateway Community Services in Jacksonville, Florida."

Answered by AI

Could you please summarize the findings of other research projects involving Buprenorphine Injection?

"Right now, there are 60 different ongoing studies evaluating Buprenorphine Injection's efficacy. Out of these, 14 have progressed to Phase 3 testing. Most trials for this medication are being conducted in White River Junction, Vermont; however, there are a total of 243 locations running clinical trials for Buprenorphine Injection around the world."

Answered by AI

From how many different sites is this research being monitored?

"The trial is being conducted out of Pregnancy Recovery Center at Magee-Womens Hospital of UPMC in Pittsburgh, Pennsylvania, Gateway Community Services in Jacksonville, Florida, and Boston Medical Center in Nashville, Tennessee with 8 other locations."

Answered by AI

What is Buprenorphine Injection's primary purpose?

"Buprenorphine Injection can ameliorate symptoms associated with opioids, pruritus, pain, and septic shock."

Answered by AI

Is Buprenorphine Injection more likely to cause harm than other pain medications?

"There is some evidence from earlier clinical trials that buprenorphine injection is effective and multiple rounds of data supporting its safety, so it received a score of 3."

Answered by AI

Who else is applying?

What site did they apply to?
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
What portion of applicants met pre-screening criteria?
Did not meet criteria
~23 spots leftby Jan 2025