A Phase 4 interventional study of Placebo and Citicoline in Alcohol Dependence, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-24.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 62 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Exclusion Criteria:
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 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
Inactive ingredient matching the active comparator in appearance
Also known as: Sugar pill
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
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.
Time frame: 12 weeks
| Milestone | Placebo | Citicoline |
|---|---|---|
| Started | 29 | 33 |
| Completed | 26 | 29 |
| Not completed | 3 | 4 |
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.
| days/week | Placebo | Citicoline |
|---|---|---|
| Heavy Drinking Days Per Week | 0.23 ± 0.30 | 0.33 ± 0.38 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/26 (0%) | 0/26 (0%) | 15/26 (57.7%) |
| Citicoline | 0/29 (0%) | 0/29 (0%) | 22/29 (75.9%) |
| Event | Placebo | Citicoline |
|---|---|---|
| DrowsinessVascular disorders | 4/26 | 5/29 |
| Dry mouthGeneral disorders | 1/26 | 4/29 |
| NauseaGastrointestinal disorders | 2/26 | 4/29 |
| StomachacheGastrointestinal disorders | 3/26 | 0/29 |
| DiarrheaGastrointestinal disorders | 1/26 | 3/29 |
| HeadacheVascular disorders | 0/26 | 2/29 |
| RashSkin and subcutaneous tissue disorders | 1/26 | 1/29 |
| FatigueGeneral disorders | 1/26 | 0/29 |
| Increased appetiteGeneral disorders | 1/26 | 0/29 |
| TremorNervous system disorders | 1/26 | 0/29 |
| Age, Continuous(years) | Placebo | Citicoline | Total |
|---|---|---|---|
| Mean | 44.79 ± 9.51 | 48.70 ± 8.92 | 46.87 ± 9.33 |
| Sex: Female, Male(Participants) | Placebo | Citicoline | Total |
|---|---|---|---|
| Female | 5 | 8 | 13 |
| Male | 24 | 25 | 49 |
| Race/Ethnicity, Customized(Participants) | Placebo | Citicoline | Total |
|---|---|---|---|
| African American | 17 | 16 | 33 |
| Caucasian | 9 | 14 | 23 |
| Hispanic | 3 | 2 | 5 |
| Other | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Placebo | Citicoline | Total |
|---|---|---|---|
| United States | 29 | 33 | 62 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center