Status:
ACTIVE_NOT_RECRUITING
Maternal Brain Imaging in Opioid Use Disorder
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use Disorder
Substance-Related Disorders
Eligibility:
FEMALE
18-100 years
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 pr...
Eligibility Criteria
Inclusion
- Pregnant Women with OUD
- Age: \>18 years old
- Any subject that is currently on Buprenorphine at time of screening
- Singleton pregnancy
Exclusion
- 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
Key Trial Info
Start Date :
August 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06008990
Start Date
August 15 2023
End Date
July 31 2026
Last Update
January 8 2026
Active Locations (1)
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1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202