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Completed

NCT Number: NCT06008990

Maternal Brain Imaging in Opioid Use Disorder

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.

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Key information

Conditions

Opioid Use Disorder Buprenorphine Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Pregnancy Related Substance Use Substance-Related Disorders

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

Pregnant mother must be taking Buprenorphine

Maternal Brain MRI

Diagnostic Test

Maternal Brain MRI obtained between 24-32 week gestation

Blood Samples

Other

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.

Questionnaires

Behavioral

Participants will answer questionnaires about their medical history, pregnancy, and substance use.

Primary outcomes

  1. 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

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

    Time frame: During MRI visit between 24-32 weeks gestational age

Other outcomes

  1. Assess differences in brain gray matter volumes in pregnant women with OUD compared to pregnant women without OUD.

    Time frame: During MRI visit between 24-32 weeks gestational age

  2. Assess differences in brain white matter microstructure on Diffusion Tensor Imaging (DTI) in pregnant women with OUD compared to pregnant women without OUD.

    Time frame: During MRI visit between 24-32 weeks gestational age

  3. Correlate alterations in brain gray matter volume and DTI metrics with steady state plasma buprenorphine exposure in pregnant women with OUD

    Time frame: During MRI visit between 24-32 weeks gestational age

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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