CompletedNot Applicable

Maternal Brain Imaging in Opioid Use Disorder

United States45 participantsStarted 2023-08-15

Plain-language 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 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.

Who can participate

Age range

18 Years – 100 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: During MRI visit between 24-32 weeks gestational age

Trial details

NCT IDNCT06008990

SponsorIndiana University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Opioid Use Disorder trials