Citicoline for Alcohol Dependence

July 23, 2018 updated by: Sherwood Brown, University of Texas Southwestern Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: Placebo
Inactive ingredient matching the active comparator in appearance
Other Names:
  • Sugar pill
Active Comparator: 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.
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.
Other Names:
  • CDP-choline
  • cytidine diphosphate-choline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heavy Drinking Days Per Week
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Sherwood Brown, M.D., Ph.D., UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 28, 2014

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 072012-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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