Maternal Brain Imaging in Opioid Use Disorder
Launched by INDIANA UNIVERSITY · Aug 18, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on understanding how opioid use disorder (OUD) affects pregnant women and their babies. Researchers want to learn more about how a common treatment for OUD, called medication-assisted therapy (MAT), works during pregnancy. They are particularly interested in how the body processes this medication and how both OUD and MAT might affect different parts of the brain in mothers compared to those who do not have OUD. The goal is to find ways to improve health outcomes for both mothers and their newborns.
To participate in this study, women must be at least 18 years old and pregnant with a single baby. They can either have a history of opioid use disorder and be receiving a specific medication called buprenorphine or be pregnant without any history of OUD. Participants will undergo brain imaging tests, which are safe and help researchers gather important information. The study is currently looking for pregnant women who meet these criteria, and it's an opportunity to contribute to research that could lead to better care for mothers and their children.
Gender
FEMALE
Eligibility criteria
- • 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
About Indiana University
Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported