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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT04015869
Eligibility Criteria:
Inclusion Criteria:
* Non-treatment seeking individuals with current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder (AUD)
* No current substance use disorder (except tobacco, alcohol, and marijuana)
* No current medical problems and normal electrocardiogram (ECG)
* For women, not pregnant as determined by pregnancy screening, not breast feeding.
Exclusion Criteria:
* Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
* History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
* Liver function tests (ALT or AST) greater than 3 times normal
* weight \>120kg
* renal impairment
* patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT04015869
Study Brief:
Protocol Section:
NCT04015869