This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic Veterans.
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 Veterans 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 Veteran sample, the investigators will include Veterans with co-morbid mood and anxiety disorders. The investigators also plan to explore the interaction between genotype and medication on drinking outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose
Placebo
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 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 (PSNHDD)
Percentage of Subjects with No Heavy Drinking Days (PSNHDD) The PSNHDD can be derived from each subject's timeline follow back (TLFB) data.
Time frame: Baseline
Gamma Glutamyl Transferase (GGT)
Difference between groups on change in levels of Gamma glutamyl transferase (GGT) over time from baseline to endpoint, which will include several interim data points. This will analyzed with a mixed models longitudinal analysis (repeated measures). Normal range for GGT levels are 10 U/L - 65 U/L - above 65 U/L above 65 U/L is considered a high GGT level
Time frame: Baseline, Week 4, 8 and 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) during the time spent on the target dose of the medication. Performed using a mixed models longitudinal analysis (repeated measures).
Time frame: over 16 weeks (weeks 1-16)
Alcohol Urge Questionnaire Score (AUQ)
This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures. The AUQ is a 8 item participant rated questionnaire. Participants indicate how much they agree or disagree with the statements by selecting one number, 1 strongly disagree through 7 strongly agree. Participants can scores between 8 (lowest) - 56 (highest), the higher the score the more urge to drink.
Time frame: over 16 weeks (weeks 1-16)
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Change in Quality of Life
Change in quality of life scores measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a 16 item participant rated questionnaire. Participants indicate how they are feeling over the 16 item from Very poor (1), Poor (2), Fair (3), Good (4), and Very Good (5). Participants can scores between 14 (lowest) - 70 (highest) the higher the score more satisfied with quality of life.
Time frame: Over 16 weeks (Baseline and 16 weeks)
Level of Alcohol-related Problems (SIP)
Change in level of alcohol-related problems measured by the Short Index of Problems (SIP). The SIP is a 15 item participant rated questionnaire. Participants rate the number of events that drinkers sometimes experience. Participants indicate how often each of the items has happened. They are scored by selecting one number, 0 Never; 1 Once or a few times; 2 Once or twice a week; 3 Daily or almost daily. Participants can scores between 0 (lowest) - 45 (highest) - the higher score the more drinking problems.
Time frame: over 16 weeks (Baseline and Week 16)