Maternal Brain Imaging in Opioid Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
- •Any contraindications for MRI
- •Opioid or polysubstance abuse as identified on urine screening
Arms & Interventions
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Intervention: Buprenorphine (Drug)
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Intervention: Maternal Brain MRI (Diagnostic Test)
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Intervention: Blood Samples (Other)
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Intervention: Questionnaires (Behavioral)
Pregnant Mothers
Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
Intervention: Maternal Brain MRI (Diagnostic Test)
Pregnant Mothers
Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
Intervention: Questionnaires (Behavioral)
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(During MRI visit between 24-32 weeks gestational age)
Investigators
Rupa Radhakrishnan
Associate Professor of Radiology & Imaging Sciences
Indiana University