Maternal Brain Imaging in Opioid Use Disorder

Indiana University

Status: Active, not recruiting

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

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06008990

1R03DA056797-01A1 (U.S. NIH Grant/Contract)

RADY-IIR-19466

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

40 participants in 2 patient groups

Pregnant Mothers with Opioid Use Disorder

Description:

Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.

Treatment:

Behavioral: Questionnaires

Diagnostic Test: Maternal Brain MRI

Drug: Buprenorphine

Other: Blood Samples

Pregnant Mothers

Description:

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

Treatment:

Behavioral: Questionnaires

Diagnostic Test: Maternal Brain MRI