Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT02074735
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2014-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Citicoline for Alcohol Dependence
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Citicoline for Alcohol Dependence
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: