Clinical trial NCT06008990: Maternal Brain Imaging in Opioid Use Disorder
Official title: Maternal Brain Imaging in Opioid Use Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Use Disorder
Substance-Related Disorders
Substance Use
Pregnancy Related
Narcotic-Related Disorders
Buprenorphine Dependence
Keywords: Pregnant with Opioid Use Disorder
Opioid Use Disorder
Subutex
Buprenorphine
Pregnant taking buprenorphine/subutex
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

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

Primary outcomes:
measure: 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.
timeFrame: During MRI visit between 24-32 weeks gestational age
Secondary outcomes:
measure: Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD
timeFrame: During MRI visit between 24-32 weeks gestational age
Other outcomes:
measure: Assess differences in brain gray matter volumes in pregnant women with OUD compared to pregnant women without OUD.
timeFrame: During MRI visit between 24-32 weeks gestational age
measure: Assess differences in brain white matter microstructure on Diffusion Tensor Imaging (DTI) in pregnant women with OUD compared to pregnant women without OUD.
timeFrame: During MRI visit between 24-32 weeks gestational age
measure: Correlate alterations in brain gray matter volume and DTI metrics with steady state plasma buprenorphine exposure in pregnant women with OUD
timeFrame: During MRI visit between 24-32 weeks gestational age
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
References: