Maternal Brain Imaging in Opioid Use Disorder
Completed
Conditions studied: Opioid Use Disorder, Substance-Related Disorders, Substance Use, Pregnancy Related, Narcotic-Related Disorders, Buprenorphine Dependence
In brief
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.
Key facts
- Study ID
- NCT06008990
- Run by
- Indiana University
- People needed
- 45
- Starts
- 2023-08-15
- Expected to finish
- 2025-10-31
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Age: >18 years old
- Any subject that is currently on Buprenorphine at time of screening
- Singleton pregnancy
You may not qualify if…
- 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
Where it is running
- Riley Hospital for Children — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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