Citicoline for Alcohol Dependence
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Heavy Drinking Days Per Week [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Southwestern Medical CEnter | Dallas | Texas | United States | 75390 |
Sponsors and Collaborators
- University of Texas Southwestern Medical Center
Investigators
- Principal Investigator: Sherwood Brown, M.D., Ph.D., UT Southwestern Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 072012-088
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Citicoline |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 29 | 33 |
| COMPLETED | 26 | 29 |
| NOT COMPLETED | 3 | 4 |
Baseline Characteristics
| Arm/Group Title | Placebo | Citicoline | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 29 | 33 | 62 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
44.79
(9.51)
|
48.70
(8.92)
|
46.87
(9.33)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
17.2%
|
8
24.2%
|
13
21%
|
| Male |
24
82.8%
|
25
75.8%
|
49
79%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| African American |
17
58.6%
|
16
48.5%
|
33
53.2%
|
| Caucasian |
9
31%
|
14
42.4%
|
23
37.1%
|
| Hispanic |
3
10.3%
|
2
6.1%
|
5
8.1%
|
| Other |
0
0%
|
1
3%
|
1
1.6%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
29
100%
|
33
100%
|
62
100%
|
Outcome Measures
| Title | Heavy Drinking Days Per Week |
|---|---|
| Description | 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. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Citicoline |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 26 | 29 |
| Mean (Standard Deviation) [days/week] |
0.23
(0.30)
|
0.33
(0.38)
|
Adverse Events
| Time Frame | 12 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Placebo | Citicoline | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Placebo | Citicoline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/29 (0%) | ||
Serious Adverse Events |
||||
| Placebo | Citicoline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/29 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Citicoline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/26 (57.7%) | 22/29 (75.9%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 2/26 (7.7%) | 4/29 (13.8%) | ||
| Diarrhea | 1/26 (3.8%) | 3/29 (10.3%) | ||
| Stomachache | 3/26 (11.5%) | 0/29 (0%) | ||
| General disorders | ||||
| Dry mouth | 1/26 (3.8%) | 4/29 (13.8%) | ||
| Increased energy | 0/26 (0%) | 1/29 (3.4%) | ||
| Fatigue | 1/26 (3.8%) | 0/29 (0%) | ||
| Increased appetite | 1/26 (3.8%) | 0/29 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Bruising | 0/26 (0%) | 1/29 (3.4%) | ||
| Nervous system disorders | ||||
| Tremor | 1/26 (3.8%) | 0/29 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 1/26 (3.8%) | 1/29 (3.4%) | ||
| Vascular disorders | ||||
| Headache | 0/26 (0%) | 2/29 (6.9%) | ||
| Hypertension | 0/26 (0%) | 1/29 (3.4%) | ||
| Drowsiness | 4/26 (15.4%) | 5/29 (17.2%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | E. Sherwood Brown, MD, PhD |
|---|---|
| Organization | UT Southwestern Medical Center |
| Phone | 214-645-6950 |
| sherwood.brown@utsouthwestern.edu |
- 072012-088