Trials / Completed
CompletedNCT02074735
Citicoline for Alcohol Dependence
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Inactive ingredient matching the active comparator in appearance |
| 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. |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2016-10-01
- Completion
- 2016-11-01
- First posted
- 2014-02-28
- Last updated
- 2018-07-24
- Results posted
- 2018-07-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02074735. Inclusion in this directory is not an endorsement.