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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT04240392
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Females age 18 or older
* Documented pregnancy in the medical record at less than 34 weeks gestation
* Delivery date no later than July 1, 2024
* Willingness to adhere to the study schedule
* Confirmed opioid use disorder by the DSM-5 Opioid Use Disorder questionnaire
* Ability to communicate in English
* No current plan to move out of the obstetrical provider treatment area within the study timeframe of approximately 44 weeks
Exclusion Criteria:
* Experiencing cognitive or emotional impairment that precludes the participant from providing informed consent
* Current hospitalization, incarceration, or institutionalization (if women present for care after institutionalization, participation is possible
* Current court case pending that would make incarceration likely during the study treatment period (approximately 44 weeks)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04240392
Study Brief:
Protocol Section:
NCT04240392