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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT02074735
Eligibility Criteria:
Inclusion Criteria:
* Men and women age 18-75 years old with diagnosis of alcohol dependence
* Average alcohol use of at least 28 drinks per week and at least 7 heavy drinking days (defined as 4 or more drinks/day for women, 5 or more drinks/day for men) in the past 28 days
* No alcohol use within 72 hours of randomization (maximum abstinence 7 days)
* CIWA-Ar (withdrawal scale) score less than or equal to 8 at randomization (consistent with minimal or no withdrawal symptoms and medication probably not needed)
Exclusion Criteria:
* Vulnerable populations including individuals with intellectual disability or dementia, prison or jail inmates, pregnant or nursing women, or women of childbearing age who will not use acceptable forms of birth control
* History of arrhythmias
* Myocardial infarction or coronary artery bypass graft surgery in the past 6 months
* Active angina or blood pressure \>170/105
* High risk for suicide (defined as suicide attempt in past 6 months, or current suicidal ideation with plan and intent)
* High risk of violence toward others (defined as assault in past 6 months, or violent thoughts with evidence of plan and intent)
* Intensive outpatient treatment for substance abuse (AA, NA meetings or weekly therapy/counseling for substance use for at least 28 days prior to randomization will be allowed)
* Dependence (not just abuse) on substances other than alcohol or nicotine
* History of delirium tremens or other sever alcohol withdrawal symptoms, history of cirrhosis or AST or ALT \>3 times normal, or other unstable medical condition (e.g. uncontrolled diabetes)
* History of bipolar disorder or schizophrenia
* Current major depressive episode (past episodes and current milder depressive symptoms allowed) or other psychiatric disorder that should be a major focus of treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02074735
Study Brief:
Protocol Section:
NCT02074735