Maternal Brain Imaging in Opioid Use Disorder

N/AActive Not RecruitingNCT06008990

Indiana University40 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Blood SamplesOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD