Understanding how opioid use disorder affects pregnant women and their babies
Maternal Brain Imaging in Opioid Use Disorder
This study looks at how opioid use disorder during pregnancy affects mothers and their babies, focusing on those using a specific treatment called buprenorphine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06008990 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate opioid use disorder (OUD) during pregnancy and its impact on both mothers and newborns. The study will involve pregnant women with OUD who are receiving medication-assisted therapy, specifically buprenorphine, and will assess how this medication is metabolized during pregnancy. Additionally, the study will utilize brain imaging techniques to compare the brain function of mothers with OUD to those without. Blood samples and questionnaires will also be collected to gather comprehensive data on maternal health and substance use.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old who are currently on buprenorphine and have a singleton pregnancy.
Not a fit: Patients who may not benefit from this study include those with serious maternal medical illnesses, HIV/AIDS, or significant mental health issues.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for pregnant women with opioid use disorder and better outcomes for their infants.
How similar studies have performed: Other studies have explored the effects of opioid use during pregnancy, but this specific approach focusing on brain imaging and medication metabolism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Riley Hospital for Children — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Rupa Radhakrishnan, MS, MD
- Email: rradhak@iu.edu
- Phone: (317) 963-0156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.