Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
40 participants
OBSERVATIONAL
2023-08-15
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Buprenorphine
Pregnant mother must be taking Buprenorphine
Maternal Brain MRI
Maternal Brain MRI obtained between 24-32 week gestation
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.
Questionnaires
Participants will answer questionnaires about their medical history, pregnancy, and substance use.
Pregnant Mothers
Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
Maternal Brain MRI
Maternal Brain MRI obtained between 24-32 week gestation
Questionnaires
Participants will answer questionnaires about their medical history, pregnancy, and substance use.
Interventions
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Buprenorphine
Pregnant mother must be taking Buprenorphine
Maternal Brain MRI
Maternal Brain MRI obtained between 24-32 week gestation
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.
Questionnaires
Participants will answer questionnaires about their medical history, pregnancy, and substance use.
Eligibility Criteria
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Inclusion Criteria
* Any subject that is currently on Buprenorphine at time of screening
* Singleton pregnancy
Exclusion Criteria
* 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
18 Years
100 Years
FEMALE
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Indiana University
OTHER
Responsible Party
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Rupa Radhakrishnan
Associate Professor of Radiology & Imaging Sciences
Locations
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Riley Hospital for Children
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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RADY-IIR-19466
Identifier Type: -
Identifier Source: org_study_id
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