Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT06415994
Eligibility Criteria:
Pregnant women with opioid use disorder
Inclusion Criteria:
* Age \>18 years
* Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
* Singleton Pregnancy
* Planned delivery at Indiana University or University of Pittsburgh study sites
Exclusion Criteria:
* Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
* Known or suspected major fetal/ neonatal congenital abnormalities
* HIV or AIDS
Infants with prenatal opioid exposure:
Inclusion:
1. Prenatal buprenorphine or methadone exposure
2. Born to mother enrolled in Opioid Use Disorder arm of study
Exclusion:
Major congenital anomalies or genetic syndromes affecting neurodevelopment
Control Pregnant Women:
Inclusion:
1. Women \>18 Years of age
2. Healthy singleton pregnancy
3. Planned delivery at Indiana University or University of Pittsburgh study sites
Exclusion:
1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
2. HIV or AIDS
3. Known or suspected major fetal congenital abnormalities
4. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.
Control infants:
Inclusion:
Born to control pregnant mother enrolled in study
Exclusion:
Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06415994
Study Brief:
Protocol Section:
NCT06415994