Citicoline for Alcohol Dependence

A total of 62 outpatients with alcohol dependence will be enrolled in a 12-week, randomized,
placebo-controlled trial. Participants will be randomized to receive either placebo or
citicoline.

Throughout the study, participants will be asked about their alcohol use and any withdrawal
or craving symptoms. Depressive symptoms will be measured as well. Cognition and memory will
be measured as well with a neurocognitive battery. Blood will be drawn at study start and
week 12 to measure liver enzyme levels.

Appointments will be weekly for the entire study. Participants will have a physician
follow-up at every study appointment.

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