Trials / Active Not Recruiting
Active Not RecruitingNCT06008990
Maternal Brain Imaging in Opioid Use Disorder
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- Indiana University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Opioid Use Disorder
- Substance-Related Disorders
- Substance Use
- Pregnancy Related
- Narcotic-Related Disorders
- Buprenorphine Dependence
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buprenorphine | Pregnant mother must be taking Buprenorphine |
| DIAGNOSTIC_TEST | Maternal Brain MRI | Maternal Brain MRI obtained between 24-32 week gestation |
| OTHER | 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. |
| BEHAVIORAL | Questionnaires | Participants will answer questionnaires about their medical history, pregnancy, and substance use. |
Timeline
- Start date
- 2023-08-15
- Primary completion
- 2026-04-01
- Completion
- 2026-07-31
- First posted
- 2023-08-24
- Last updated
- 2026-01-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06008990. Inclusion in this directory is not an endorsement.