Clinical trial NCT02074735: Citicoline for Alcohol Dependence
Official title: Citicoline for Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Dependence
Keywords: alcohol dependence
alcohol abuse
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if citicoline, as an add-on therapy, will help reduce alcohol use in outpatients with alcohol dependence.

Detailed description: 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.

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

Primary outcomes:
measure: Heavy Drinking Days Per Week
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical CEnter
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Sherwood Brown, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: