Maternal Brain Imaging in Opioid Use Disorder

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06008990

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder Substance-Related Disorders Substance Use Pregnancy Related Narcotic-Related Disorders Buprenorphine Dependence	Drug: Buprenorphine Diagnostic Test: Maternal Brain MRI Other: Blood Samples Behavioral: Questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Maternal Brain Imaging in Opioid Use Disorder

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

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. [During MRI visit between 24-32 weeks gestational age]

Secondary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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