This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic civilians.
This is a 16-week randomized, double blind, placebo-controlled trial designed to determine the effectiveness of zonisamide treatment for reducing heavy drinking and overall drinking in 160 treatment-seeking, regularly heavy drinking, alcohol-dependent civilians who want to quit drinking or reduce consumption to non-hazardous levels. The investigators will use state-of-the-art methodology and outcome assessments, including medical management (MM) therapy (a minimal behavioral intervention aimed at reinforcing treatment goals and adherence to medication), which is simple and easily implemented in primary care settings. The use of MM in the study will increase the generalizability of results, allowing a more accurate assessment of zonisamide's effectiveness than if a more intensive behavioral intervention were to be used. To demonstrate zonisamide's effectiveness in a representative civilian sample, the investigators will include civilians with co-morbid mood and anxiety disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose
Placebo
UCONN Health
Farmington, Connecticut, United States
Yale University
New Haven, Connecticut, United States
West Haven Veterans Affairs
West Haven, Connecticut, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Number of Drinks Per Week
Difference between groups in the number of total standard drinks per week over 8 weeks (weeks 9-16, the weeks on the target dose) performed using a mixed models longitudinal analysis.
Time frame: over 8 weeks (weeks 9-16)
Percentage of Subjects With No Heavy Drinking Days
percentage of subjects with no heavy drinking days (PSNHDD) The PSNHDD can be derived from each subject's Timeline Followback (TLFB) data.
Time frame: over the last 8 weeks (weeks 9-16)
Gamma Glutamyl Transferase (GGT) Levels
Difference between groups on levels of GGT over time from baseline to endpoint, which will includes two interim data points for a total of four time points. This will analyzed with a mixed models longitudinal analysis (repeated measures). Levels are in Units per Liter.
Time frame: over 16 weeks (weeks 1-16)
Number of Heavy Drinking Days Per Week
The difference in the number of heavy drinking days per week compared between groups (zonisamide and placebo) for the last 8 weeks of treatment (during the time spent on the target dose of the medication). Performed using a mixed models longitudinal analysis (repeated measures).
Time frame: over the last 8 weeks (weeks 9-16)
Change in Alcohol Urge Questionnaire Score (AUQ)
This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures Min value: 8 Max value: 42 higher score = worse craving
Time frame: over 16 weeks (weeks 1-16) and at 2 week and 3 month follow up
Change in Quality of Life
Change in quality of life scores measured by the Q-LES-Q. ' Min: 16 Max: 80 Higher Scores = Higher Life Enjoyment
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Time frame: over 16 weeks (weeks 1-16) and at 2 week and 3 month follow up
Level of Alcohol-related Problems
level of alcohol-related problems measured by the Short Index of Problems (SIP), total score Min score: 0 Max Score: 45 Higher score= more problems
Time frame: over 16 weeks (weeks 1-16) and at 2 week and 3 month follow up