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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT07118618
Eligibility Criteria:
Inclusion Criteria:
* • Male or female, ≥18 years.
* women \>7 drinks/week; men \>14 drinks/week.
* meet moderate to severe AUD score for DSM-5 criteria.
* Breath Alcohol Content (BrAC)=0.00 at each visit.
* in good health as confirmed by medical history, physical examination and lab tests.
* willing to adhere to the study procedures.
* understand informed consent and questionnaires in English at an 8th grade level.
Exclusion Criteria:
* • Women who are breastfeeding or positive urine test for pregnancy.
* clinically significant medical abnormalities: unstable hypertension, clinically significant abnormal EKG, bilirubin \>150% of the upper normal limit, ALT/AST \>300% the UNL, creatinine clearance ≤60 dl/min
* meet DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
* medications that reduce alcohol consumption (naltrexone, disulfiram).
* use aspirin (salicylates may reduce effect of probenecid), penicillin, methotrexate (may increase concentration).
* history of suicide attempts in the last three years.
* current diagnosis of a moderate or severe cannabis use disorder as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.
* current diagnosis of another substance disorder at any severity, other than nicotine, as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.
* current use of medications that may interact with probenecid.
* history of hypersensitivity to sulfa drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07118618
Study Brief:
Protocol Section:
NCT07118618