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Opioid Agonist

Buprenorphine for Opioid Use Disorder in Pregnancy (MOMs-INO Trial)

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-partum
Awards & highlights

MOMs-INO Trial Summary

This trial will compare the effects of two different types of medication to treat opioid addiction in pregnant women on their infants' neurodevelopment.

Who is the study for?
This trial is for caretakers of infants born to mothers who were part of the MOMs trial, which looked at opioid use disorder treatments during pregnancy. The study focuses on how two forms of buprenorphine affect the baby's brain development.Check my eligibility
What is being tested?
The sub-study compares extended-release buprenorphine injections (BUP-XR) with sublingual products (BUP-SL) to see their impact on infant neurodevelopment. It extends research from the main MOMs trial involving expectant mothers with opioid addiction.See study design
What are the potential side effects?
While specific side effects in infants are not detailed here, buprenorphine can sometimes cause drowsiness, respiratory issues, and feeding difficulties. Close monitoring by healthcare providers is essential.

MOMs-INO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-partum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-partum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Bayley Scales of Infant Development
Child Behavior Checklist

MOMs-INO 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?

T. John Winhusen, PhDLead Sponsor
3 Previous Clinical Trials
357 Total Patients Enrolled
3 Trials studying Substance Abuse
357 Patients Enrolled for Substance Abuse
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,149 Total Patients Enrolled
152 Trials studying Substance Abuse
706,942 Patients Enrolled for Substance Abuse
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,291 Total Patients Enrolled
2 Trials studying Substance Abuse
237 Patients Enrolled for Substance Abuse

Media Library

Buprenorphine Injection (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03911739 — Phase 3
Substance Abuse Research Study Groups: BUP-XR, BUP-SL
Substance Abuse Clinical Trial 2023: Buprenorphine Injection Highlights & Side Effects. Trial Name: NCT03911739 — Phase 3
Buprenorphine Injection (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03911739 — Phase 3

Frequently Asked Questions

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

Does Buprenorphine Injection carry a high risk for adverse effects?

"Buprenorphine Injection is estimated to be a safe medication, as it has progressed to Phase 3 clinical trials. This means that not only does the drug have some evidence supporting its efficacy, but there is also multiple rounds of data affirming its safety."

Answered by AI

What is the geographic distribution of where this experiment is being conducted?

"This study is being conducted at various locations including but not limited to Gateway Community Services in Jacksonville, Florida, Vanderbilt University Medical Center in Nashville, Tennessee, and University of Utah SUPeRAD Clinic in Salt Lake City, Utah."

Answered by AI

In this experiment, how many people are receiving the treatment?

"The Emmes Company, LLC is looking for 200 individuals that meet the specific inclusion criteria for their clinical trial. This research will be conducted at multiple locations, two of which are Gateway Community Services in Jacksonville, Florida and Vanderbilt University Medical Center in Nashville, Tennessee."

Answered by AI

What does Buprenorphine Injection help alleviate symptoms for?

"Buprenorphine Injection is commonly used to ameliorate the effects of opioids, however it can also help with other conditions like pruritus, pain, and septic shock."

Answered by AI

Are there any other examples of Buprenorphine being used as medication?

"There are currently 60 Buprenorphine Injection studies underway. Of those, 14 have reached Phase 3 and are ongoing. The majority of these trials originated in White River Junction, Vermont; however, there are 243 total locations where patients can receive this treatment."

Answered by AI

Can patients currently sign-up to participate in this research?

"That is correct, the information available on clinicaltrials.gov indicates that this trial is still enrolling patients. The study was originally posted on June 14th, 2021 and edited most recently on November 11th, 2022. They are looking for 200 individuals total from 8 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Utah
How old are they?
18 - 65
What site did they apply to?
Vanderbilt University Medical Center
University of Utah SUPeRAD Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
T. John Winhusen, PhD 2021. "Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911739.
All > Substance Abuse > Probuphine
~42 spots leftby Jan 2025
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