Trial Outcomes & Findings for Citicoline for Alcohol Dependence (NCT NCT02074735)
NCT ID: NCT02074735
Last Updated: 2018-07-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-07-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
33
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Citicoline for Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
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
n=33 Participants
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
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.79 years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
48.70 years
STANDARD_DEVIATION 8.92 • n=7 Participants
|
46.87 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksHeavy 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.
Outcome measures
| Measure |
Placebo
n=26 Participants
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
n=29 Participants
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.
|
|---|---|---|
|
Heavy Drinking Days Per Week
|
0.23 days/week
Standard Deviation 0.30
|
0.33 days/week
Standard Deviation 0.38
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Citicoline
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=26 participants at risk
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
n=29 participants at risk
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.
|
|---|---|---|
|
General disorders
Dry mouth
|
3.8%
1/26 • 12 weeks
|
13.8%
4/29 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • 12 weeks
|
13.8%
4/29 • 12 weeks
|
|
Vascular disorders
Headache
|
0.00%
0/26 • 12 weeks
|
6.9%
2/29 • 12 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • 12 weeks
|
3.4%
1/29 • 12 weeks
|
|
Vascular disorders
Drowsiness
|
15.4%
4/26 • 12 weeks
|
17.2%
5/29 • 12 weeks
|
|
General disorders
Increased energy
|
0.00%
0/26 • 12 weeks
|
3.4%
1/29 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • 12 weeks
|
10.3%
3/29 • 12 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/26 • 12 weeks
|
3.4%
1/29 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
1/26 • 12 weeks
|
3.4%
1/29 • 12 weeks
|
|
General disorders
Fatigue
|
3.8%
1/26 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
|
General disorders
Increased appetite
|
3.8%
1/26 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
|
Nervous system disorders
Tremor
|
3.8%
1/26 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
|
Gastrointestinal disorders
Stomachache
|
11.5%
3/26 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
Additional Information
E. Sherwood Brown, MD, PhD
UT Southwestern Medical Center
Phone: 214-645-6950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place