Citicoline for Alcohol Dependence

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo schedule will mimic the schedule of the active comparator citicoline. Placebo will be started at the randomization visit (week 0, mimicking 500 mg/day of citicoline), then increased at week 2 to mimic 1000 mg/day citicoline, then increased to mimic 1500 mg/day of citicoline at week 4, and then increased to mimic 2000 mg/day of citicoline at week 6 until the end of week 12.
Citicoline	Citicoline	Citicoline will be started at 500 mg/day at the randomization visit (week 0), then increased to 1000 mg/day at week 2, then 1500 mg/day at week 4, and then 2000 mg/day at week 6 until the end of week 12.

Primary Outcome Measures

Name	Time	Method
Heavy Drinking Days Per Week	12 weeks	Heavy drinking days are defined as "4 or more drinks for women, 5 or more drinks for men in a single day". Participants self-reported the type and amount of alcohol consumed during each assessment period. From this information, number of standard drinks per day was calculated using the following formula: "(number of drinks) x (oz per drink) x (alcohol by volume or ABV)". The average number of heavy drinking days was calculated by dividing the number of heavy drinking days per week by the number of days in the assessment period.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility