Maternal Brain Imaging in Opioid Use Disorder

May 19, 2026 updated by: Rupa Radhakrishnan, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.

Description

Pregnant Women with OUD

Inclusion Criteria:

  • Age: >18 years old
  • Any subject that is currently on Buprenorphine at time of screening
  • Singleton pregnancy

Exclusion Criteria:

  • Serious maternal medical illness
  • HIV or AIDs
  • Polysubstance use
  • Score >9 on the PHQ-9, and score >0 on item 9 which is about suicidality
  • Score of 8 or more on GAD-7
  • Any contraindications for MRI
  • Known or suspected major fetal congenital abnormalities

Pregnant Women with no history of OUD

Inclusion:

  • Age: >18 years old
  • Singleton pregnancy

Exclusion:

  • Serious maternal medical illness
  • HIV or AIDS
  • Score of >9 on the PHQ-9, and a score of >0 on item 9 which is about suicidality
  • Score of 8 or more on GAD-7
  • Known or suspected major fetal congenital abnormalities
  • Any contraindications for MRI
  • Opioid or polysubstance abuse as identified on urine screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Drug: Buprenorphine
Pregnant mother must be taking Buprenorphine
Diagnostic test: Maternal Brain MRI
Maternal Brain MRI obtained between 24-32 week gestation
Other: Blood Samples
During the MRI visit blood samples will be drawn: one hour prior to MRI, immediately before MRI, and one hour post MRI to test for Buprenorphine levels.
Behavioral: Questionnaires
Participants will answer questionnaires about their medical history, pregnancy, and substance use.
Pregnant Mothers
Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
Diagnostic test: Maternal Brain MRI
Maternal Brain MRI obtained between 24-32 week gestation
Behavioral: Questionnaires
Participants will answer questionnaires about their medical history, pregnancy, and substance use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: During MRI visit between 24-32 weeks gestational age
During MRI visit between 24-32 weeks gestational age

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD
Time Frame: During MRI visit between 24-32 weeks gestational age
During MRI visit between 24-32 weeks gestational age

Other Outcome Measures

Outcome Measure
Time Frame
Assess differences in brain gray matter volumes in pregnant women with OUD compared to pregnant women without OUD.
Time Frame: During MRI visit between 24-32 weeks gestational age
During MRI visit between 24-32 weeks gestational age
Assess differences in brain white matter microstructure on Diffusion Tensor Imaging (DTI) in pregnant women with OUD compared to pregnant women without OUD.
Time Frame: During MRI visit between 24-32 weeks gestational age
During MRI visit between 24-32 weeks gestational age
Correlate alterations in brain gray matter volume and DTI metrics with steady state plasma buprenorphine exposure in pregnant women with OUD
Time Frame: During MRI visit between 24-32 weeks gestational age
During MRI visit between 24-32 weeks gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADY-IIR-19466
  • 1R03DA056797-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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