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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT02542150
Eligibility Criteria:
Inclusion Criteria-all:
1. Subjects who are age 21-55,
2. Subjects who are proficient in English ,
3. Subjects who understand the nature of the study,
4. Subjects who have signed an informed consent,
5. Subjects who are non-smoking (defined as fewer than 20 cigarettes lifetime),
Inclusion Criteria-moderate drinkers:
1. Subjects who are moderate drinkers (male:1-14 drinks per week; female: 1-7 drinks per week).
2. Subjects who have drunk at least 2 drinks in one hour in the past, and have no history of dependence on drugs or alcohol
Inclusions-AUD:
(1) Subjects who meet DSM-V criteria for lifetime history of Alcohol Use Disorder (AUD)
Exclusion Criteria-all:
1. Subjects who have a "facial flushing" response to alcohol,
2. Subjects who are pregnant or nursing,
3. Subjects who have major medical problems including diabetes, high blood pressure (\> 150/90), prior neurological or psychiatric history (schizophrenia, bipolar, or current major depressive disorder), epilepsy (alcohol withdrawal seizures is not an exclusion),
4. Subjects who have been told they have or been diagnosed with liver or kidney disease,
5. Subjects who have chronic gastrointestinal disease,
6. Subjects who are obese (BMI\>30 kg/m2),
7. Subjects who take psychoactive medications,
8. Subjects who have prior head trauma resulting in loss of consciousness \>15 minutes,
9. Subjects who have Magnetic Resonance (MR) exclusions which include claustrophobia, intracranial, orbital, or spinal metal implants, pacemakers, cochlear implants, cardiac stents or other non-MR-compatible implants or devices.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT02542150
Study Brief:
Protocol Section:
NCT02542150