Citicoline for Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:

Citicoline for Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074735
• Other study ID #: 072012-088
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: November 2016

Study information

• Verified date: July 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Placebo
Inactive ingredient matching the active comparator in appearance
• Citicoline
Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body.

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical CEnter	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heavy Drinking Days Per Week	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.	12 weeks