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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT04822168
Eligibility Criteria:
Inclusion Criteria:
* age 18 to 65 years
* opioid use disorder
* stepping down from inpatient detox services
* willing to engage in daily outpatient supervised dosing of B/N.
Exclusion Criteria:
* cognitively impaired (Unable to complete consent quiz at 90% accuracy AND MOCA \< 25/30 relative exclusion requiring PI approval, absolute exclusion for MOCA\<21/30) (Nasreddine,et al., 2005)
* homeless without any expressed interest in attaining housing after detox discharge
* reporting active homicidal or suicidal ideation with an imminent plan
* current mania or psychosis
* expected incarceration in next 3 months (those that are incarcerated during the study will be removed from the study)
* unable or unwilling to use a mobile device
* medical contraindication to B/N
* unable to complete baseline assessments
* unstable medical illness who expect hospitalization in the next 3 months
* pregnant women (if a patient becomes pregnant while participating in this study, they will be withdrawn)
* prisoners
* court-ordered individuals
* is non-English speaking
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04822168
Study Brief:
Protocol Section:
NCT04822168