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Effects of Levetiracetam (Keppra) on Alcohol Consumption

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ClinicalTrials.gov Identifier: NCT01168687
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : February 25, 2013
Last Update Posted : February 25, 2013
Sponsor:
Collaborators:
United States Department of Defense
University of California
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Alcohol Abuse
Drug Abuse
Interventions Drug: Levetiracetam (Keppra)
Drug: Placebo
Enrollment 46
Recruitment Details Recruitment was conducted online (Craigslist) and from publicly posted flyers.
Pre-assignment Details Enrolled participants were excluded prior to medication dosing if blood testing revealed elevated liver enzymes or if urine testing indicated a pregnancy.
Arm/Group Title Group A: Crossover Between Low Dose Keppra and Placebo Group B: Crossover Between High Dose Keppra and Placebo
Hide Arm/Group Description Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.

Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.

Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.

Period Title: Overall Study
Started 23 23
Completed 23 23
Not Completed 0 0
Arm/Group Title Group A: Crossover Between Low Dose Keppra and Placebo Group B: Crossover Between High Dose Keppra and Placebo Total
Hide Arm/Group Description Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.

Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.

Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.

Total of all reporting groups
Overall Number of Baseline Participants 23 23 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
23
 100.0%
46
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
12
  52.2%
12
  52.2%
24
  52.2%
Male
11
  47.8%
11
  47.8%
22
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 23 participants 46 participants
23 23 46
1.Primary Outcome
Title Standard Alcoholic Drinks Per Treatment Period
Hide Description The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period.
Time Frame This will be assessed during a 42-day period.
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants were used for data analysis. If there were no significant differences between the two doses of levetiracetam, data would be collapsed for analysis.
Arm/Group Title All Subjects (n = 46) Placebo All Subjects (n = 46) Levetiracetam
Hide Arm/Group Description:
23 moderate social drinkers. 23 heavy social drinkers.
23 moderate social drinkers. 23 heavy social drinkers.
Overall Number of Participants Analyzed 46 46
Mean (Standard Error)
Unit of Measure: number of drinks per treatment period
41.2  (2.8) 45.4  (3.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects (n = 46) Placebo All Subjects (n = 46) Levetiracetam
Hide Arm/Group Description 23 moderate social drinkers. 23 heavy social drinkers. 23 moderate social drinkers. 23 heavy social drinkers.
All-Cause Mortality
All Subjects (n = 46) Placebo All Subjects (n = 46) Levetiracetam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects (n = 46) Placebo All Subjects (n = 46) Levetiracetam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
All Subjects (n = 46) Placebo All Subjects (n = 46) Levetiracetam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/46 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Mitchell, Clinical Project Director
Organization: Ernest Gallo Clinic and Research Center, UCSF
Phone: 510-985-3100
EMail: jmitchell@gallo.ucsf.edu
Other Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01168687     History of Changes
Other Study ID Numbers: H1815-29512-02
W81XWH-05-1-0215 ( Other Grant/Funding Number: US Dept. of the Army )
First Submitted: October 6, 2008
First Posted: July 23, 2010
Results First Submitted: January 16, 2013
Results First Posted: February 25, 2013
Last Update Posted: February 25, 2013