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Opioid Agonist
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 estimated gestational age (ega) approximately 36 weeks
Awards & highlights
MOMs-CMA 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.Check my eligibility
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.See study design
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.
MOMs-CMA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMOMs-CMA Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cmax of buprenorphine and metabolites in plasma
Cmin of buprenorphine and metabolites in plasma
Buprenorphine
+2 moreMOMs-CMA 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.).
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Who is running the clinical trial?
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,394 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,542 Total Patients Enrolled
T. John Winhusen, PhDLead Sponsor
3 Previous Clinical Trials
460 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: BUP-SL
- Group 2: BUP-XR
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been the findings of studies on the safety of Buprenorphine Injection?
"There is some evidence supporting the efficacy of buprenorphine injection, as this is a phase 3 trial. Additionally, there is safety data from multiple rounds of testing, so the Power team gave it a score of 3."
Answered by AI
What are some of the indications for Buprenorphine Injection?
"Buprenorphine Injection is commonly used to help patients ween off of opioids, but it can also serve as a form of treatment for other conditions like pruritus, pain, and septic shock."
Answered by AI
Does this study allow patients who are over 45 years old to participate?
"People who meet the age criteria of 18-41 and other inclusion criteria may apply for this trial. There are 511 other clinical trials for those under 18 and 1580 for patients over the age of 65."
Answered by AI
What is the general consensus in the medical community about Buprenorphine Injection?
"Sixty studies are currently underway for Buprenorphine Injection, 14 of which are in Phase 3. The primary research site is located in White River Junction, Vermont, but there are 243 other centres running trials for this treatment across the United States."
Answered by AI
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