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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT04311294
Eligibility Criteria:
Inclusion Criteria:
1. 21 years and older (adult, older adult);
2. meeet DSM-5 diagnostic criteria for alcohol use disorder (moderate or severe);
3. report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment.
Exclusion Criteria:
1. current treatment for alcohol problems;
2. a history of treatment for alcohol problems in the 30 days before enrollment;
3. currently seeking treatment for alcohol problems;
4. current DSM-5 diagnosis of dependence on any psychoactive substances other than alcohol or nicotine;
5. lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
6. positive urine screen for narcotics, amphetamines, or sedative hypnotics;
7. serious alcohol withdrawal symptoms as indicated by a score of ≥10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
8. pregnant, nursing, or refusal to use reliable birth control method (if female);
9. medical condition that may interfere with safe study participation (e.g. unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);
10. AST, ALT, or GGT ≥ 3 times upper limit of normal;
11. attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past year;
12. currently on prescription medication that contraindicates use of ANS-6637;
13. other circumstances that, in the opinion of the investigators, compromises participant safety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04311294
Study Brief:
Protocol Section:
NCT04311294