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Pregnant Mothers with Opioid Use Disorder for Pregnancy

N/A
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during mri visit between 24-32 weeks gestational age
Awards & highlights

Study Summary

This research study aims to learn more about opioid use disorder (OUD) during pregnancy and how outcomes for pregnant women and their newborns can be improved. During pregnancy, people with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested to know how the medication is broken down by the body during pregnancy and how effective it is. The investigators also want to learn if this medication and OUD have any effect on the different parts of the brain when compared to mothers without OUD.

Eligible Conditions
  • Pregnancy
  • Buprenorphine Dependence
  • Substance Use Disorders
  • Opioid Use Disorder
  • Substance Abuse
  • Narcotic Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during mri visit between 24-32 weeks gestational age
This trial's timeline: 3 weeks for screening, Varies for treatment, and during mri visit between 24-32 weeks gestational age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identify alterations in Default mode network connectivity in women with prenatal opioid use disorder compares to control pregnant women without OUD on maternal brain MRI.
Secondary outcome measures
Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD
Other outcome measures
Assess differences in brain gray matter volumes in pregnant women with OUD compared to pregnant women without OUD.
Assess differences in brain white matter microstructure on Diffusion Tensor Imaging (DTI) in pregnant women with OUD compared to pregnant women without OUD.
Correlate alterations in brain gray matter volume and DTI metrics with steady state plasma buprenorphine exposure in pregnant women with OUD

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pregnant Mothers with Opioid Use DisorderExperimental Treatment4 Interventions
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Group II: Pregnant MothersExperimental Treatment2 Interventions
Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Buprenorphine
2014
Completed Phase 4
~2520

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,121 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,553 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Maternal Brain Imaging in Opioid Use Disorder
Rupa Radhakrishnan 2023. "Maternal Brain Imaging in Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008990.
~24 spots leftby Apr 2025
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