Citicoline for Alcohol Dependence

NCT ID: NCT02074735

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-11-30

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.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive ingredient matching the active comparator in appearance

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.

Group Type: ACTIVE_COMPARATOR

Citicoline

Intervention Type: DRUG

Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body.

Interventions

Placebo

Inactive ingredient matching the active comparator in appearance

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Sugar pill; CDP-choline; cytidine diphosphate-choline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherwood Brown

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherwood Brown, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

The University of Texas Southwestern Medical CEnter

Dallas, Texas, United States

Countries

United States

Other Identifiers

072012-088

Identifier Type: -

Identifier Source: org_study_id