The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
11 BBCET sessions
11 BBCET Sessions
500mg - 2000mg Once per day 16 weeks
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Dartmouth Medical School
Lebanon, New Hampshire, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Time frame: Weeks 5-14
The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Time frame: Study Weeks 5-14
The Number of Drinks Per Drinking Day Study Weeks 5-14.
based on self report
Time frame: Study Weeks 5-14
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500mg - 2000mg Once per day 16 weeks
University of Virginia
Charlottesville, Virginia, United States