Maternal Brain Imaging in Opioid Use Disorder

Pregnancy Related Clinical Trial

Official title:

Maternal Brain Imaging in Opioid Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008990
• Other study ID #: RADY-IIR-19466
• Secondary ID: 1R03DA056797-01A
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: Rupa Radhakrishnan, MS, MD
• Phone: (317) 963-0156
• Email: rradhak[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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