Citicoline for Alcohol Dependence

Completed · Phase 4 · Has a placebo group

Conditions studied: Alcohol Dependence

In brief

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.

Key facts

Study ID

NCT02074735

Run by

University of Texas Southwestern Medical Center

People needed

62

Starts

2014-04-01

Expected to finish

2016-11-01

Last updated by the study team

2018-07-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• The University of Texas Southwestern Medical CEnter — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.