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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT06265506
Eligibility Criteria:
Inclusion Criteria:
1. Had 2 heavy drinking episodes (assigned male at birth \> 4 standard drinks (SDs), assigned female at birth \> 3 SDs) or ≥14 SDs in the prior 14 days verified by PEth 16:0/18:1 biomarker \> 20 ng/mL (indicates at least 2 heavy drinking episodes in past two weeks);
2. Have a DSM-5 diagnosis of a current AUD as assessed by the Structured Clinical Interview for DSM-5;
3. 18+ (individuals over 65 will be assessed for cognitive impairments)
4. Are not receiving treatment for AUD
5. Are able to complete virtual study visits via Zoom
Exclusion Criteria:
1. have a current diagnosis of severe substance use disorder (other than AUD, tobacco, and cannabis);
2. PEth biomarker ≤ 20 ng/mL (indicates no heavy drinking in past month)
3. inability to provide informed consent based on the UBACC or MacCAT-CR;
4. alcohol withdrawal-related seizure or hospitalization in prior 12 months;
5. psychiatrically or medically unsafe to participate, as assessed by the PI; and/or
6. currently enrolled in alcohol treatment or another alcohol treatment study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06265506
Study Brief:
Protocol Section:
NCT06265506