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:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT03718104
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at Boston Medical Center (BMC) or the University of North Carolina (UNC)
* Plan to deliver infant at BMC or UNC
* Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the current pregnancy on prescribed oral or extended-release naltrexone; or buprenorphine/naloxone for the treatment of OUD
* English speaking
* Singleton pregnancy
Exclusion Criteria:
* OUD on prescribed methadone, or no maintenance medication
* OUD on Subutex formulation of buprenorphine
* Severe psychiatric illness or cognitively impairing ability to provide informed consent
* Current maternal incarceration
* Women who present for care \>31 0/7 weeks
* Multiple gestation pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03718104
Study Brief:
Protocol Section:
NCT03718104