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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT06395467
Eligibility Criteria:
Inclusion criteria:
1. 14-21 years old
2. SUD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
3. able to read and comprehend English at a 5th-grade level
4. residence in New England (Massachusetts, Connecticut, Rhode Island, Vermont, New Hampshire, Maine) or New York
5. any AOD use in the past 90 days (or in the 90 days prior to being in a controlled environment)
6. meet patient placement criteria for level I (outpatient) treatment
7. participant and a family member/guardian responsible for providing collateral information (for those \<18 years) agree to sign Institutional Review Board (IRB)-approved consent
8. participant and family member responsible for providing collateral information who could be contacted in case the subject became lost to follow-up.
Exclusion criteria:
1. suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or others, or a history of self-injurious behavior occurring in past 30 days
2. lifetime diagnosis of schizophrenia
3. current health condition (i.e., medical, psychiatric) that compromises participant's ability to attend outpatient treatment
4. demonstrate inability or unwillingness to identify a "locator" who could be contacted in case participant becomes lost to follow-up; or
5. youth attending another SUD treatment program or receiving psychotherapy that could conflict with study treatments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
21 Years
Study:
NCT06395467
Study Brief:
Protocol Section:
NCT06395467