Citicoline for Alcohol Dependence

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified June 2018 by University of Texas Southwestern Medical Center
Sponsor
University of Texas Southwestern Medical Center
Information Provided by (Responsible Party)
Sherwood Brown
Clinicaltrials.gov Identifier
NCT02074735
Other Study ID Numbers:
072012-088
First Submitted
February 25, 2014
First Posted
February 27, 2014
Results First Posted
June 12, 2018
Last Update Posted
July 23, 2018
Last Verified
June 2018

ClinicalTrials.gov processed this data on July 2018. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Alcohol Dependence
Drug: PlaceboDrug: Citicoline

Study Design

Study TypeInterventional
Actual Enrollment62 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleCiticoline for Alcohol Dependence
Study Start DateMarch 31, 2014
Actual Primary Completion DateSeptember 30, 2016
Actual Study Completion DateOctober 31, 2016

Groups and Cohorts

Group/CohortIntervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures
  1. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsUniversity of Texas Southwestern Medical Center
Locations
The University of Texas Southwestern Medical CEnter | Dallas Texas, United States, 75390
Investigators
Principal Investigator: Sherwood Brown, M.D., Ph.D., University of Texas Southwestern Medical Center