Citicoline for Alcohol Dependence

NCT02074735 | Completed Phase 4 Results DMC

• 1 other identifier: 072012-088
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence

Keywords

alcohol dependence; alcohol abuse

Outcome Measures

Primary Outcomes (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.

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Citicoline

ACTIVE COMPARATOR

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

Interventions

Placebo DRUG

Inactive ingredient matching the active comparator in appearance

Also known as: Sugar pill

Placebo

Citicoline 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.

Also known as: CDP-choline, cytidine diphosphate-choline

Citicoline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical CEnter

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Sugars; Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: E. Sherwood Brown, MD, PhD
• Organization: UT Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

214-645-6950

Study Officials

• Sherwood Brown, M.D., Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 24, 2018
• Results First Posted: July 24, 2018

Record last verified: 2018-07

Locations

US (1)