Maternal Brain Imaging in Opioid Use Disorder

NCT06008990 | Active Not Recruiting

• 2 other identifiers: RADY-IIR-194661R03DA056797-01A1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use; Pregnancy Related; Narcotic-Related Disorders; Buprenorphine Dependence; Substance-Related Disorders; Opioid Use Disorder

Keywords

Pregnant with Opioid Use Disorder; Opioid Use Disorder; Subutex; Buprenorphine; Pregnant taking buprenorphine/subutex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (3)

• Assess differences in brain gray matter volumes in pregnant women with OUD compared to pregnant women without OUD.

  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.

  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

  During MRI visit between 24-32 weeks gestational age

Study Arms (2)

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; Diagnostic Test: Maternal Brain MRI; Other: Blood Samples; Behavioral: Questionnaires

Pregnant Mothers

Planned recruitment of 20 mothers who do not have any history of opioid use disorder.

Diagnostic Test: Maternal Brain MRI; Behavioral: Questionnaires

Interventions

Buprenorphine DRUG

Pregnant mother must be taking Buprenorphine

Pregnant Mothers with Opioid Use Disorder

Maternal Brain MRI DIAGNOSTIC_TEST

Maternal Brain MRI obtained between 24-32 week gestation

Pregnant Mothers; Pregnant Mothers with Opioid Use Disorder

Blood Samples OTHER

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.

Pregnant Mothers with Opioid Use Disorder

Questionnaires BEHAVIORAL

Participants will answer questionnaires about their medical history, pregnancy, and substance use.

Pregnant Mothers; Pregnant Mothers with Opioid Use Disorder

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• Age: \>18 years old
• Singleton pregnancy
• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biosamples: During the MRI visit blood samples will be collected to estimate steady-state plasma level of buprenorphine using a population pharmacokinetic approach.

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Narcotic-Related Disorders

Interventions

Buprenorphine; Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology & Imaging Sciences

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 24, 2023
• Study Start: August 15, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)