Maternal Brain Imaging in Opioid Use Disorder

Recruiting

• Conditions: Substance-Related Disorders; Substance Use; Narcotic-Related Disorders; Buprenorphine Dependence; Pregnancy Related; Opioid Use Disorder
• Interventions: Drug: Buprenorphine; Diagnostic Test: Maternal Brain MRI; Other: Blood Samples; Behavioral: Questionnaires

• Registration Number: NCT06008990
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-15
• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-24
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-04-01
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Mothers with Opioid Use Disorder	Blood Samples	Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Pregnant Mothers with Opioid Use Disorder	Questionnaires	Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Pregnant Mothers with Opioid Use Disorder	Maternal Brain MRI	Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Pregnant Mothers	Maternal Brain MRI	Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
Pregnant Mothers	Questionnaires	Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
Pregnant Mothers with Opioid Use Disorder	Buprenorphine	Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.

Primary Outcome Measures

Name	Time	Method
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.	During MRI visit between 24-32 weeks gestational age

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States