Alcohol Use Disorder
Conditions
Keywords
Alcohol Use Disorder, Alcoholism, Alcohol Dependence, Zonisamide, Alcoholic Intoxication, Drinking Behaviors, Anticonvulsants
Brief summary
This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic Veterans.
Detailed description
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.
Interventions
DRUGZonisamide
Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose
DRUGPlacebo
Placebo
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female/male veterans aged 21-70 years * Regular heavy drinkers as defined by averaging 2 heavy drinking days per week over 90 days baseline pre-treatment timeline follow-back (TLFB), and current alcohol dependence diagnosis by the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) that recognize a need to reduce or stop drinking (Note: heavy drinking days will be defined as follows; for men greater than or equal to 5 drinks in a day and for women greater than or equal to 4 drinks in a day) * Women of child-bearing potential (i.e., no hysterectomy, bilateral oophorectomy, or tubal ligation or \<2 years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment; * Willingness to provide signed, informed consent to participate in the study
Exclusion criteria
* A current, clinically significant physical disease or abnormality (i.e., neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine, cardiovascular, hepatic, or autoimmune disease that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities such as hepatic aminotransferase levels \[i.e., aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\] greater than 300% of the upper limit of normal or direct bilirubin levels \>150% of the upper limit of normal) on the basis of medical history, physical examination, or routine laboratory evaluation. Other specific exclusionary disorders include; * History of renal calculi or renal failure; a significant indication of renal compromise will be defined by an elevation of serum creatinine above the investigators' laboratory's limit of normal, or a known history of renal failure or chronic renal disease, or any current or chronic disease that could reasonably be expected to result in renal failure * History of hypersensitivity to zonisamide or any sulfonamide, Stevens-Johnson Syndrome, penicillin allergy, or history of any severe drug allergic reaction; * History of systemic autoimmune disease such as lupus erythematosis, fibromyalgia, or rheumatoid arthritis; * Current blood dyscrasia or a history of such, with the exception of a past history of iron deficiency anemia * History of seizure disorder * Use of any of a number of medications that might prominently influence drinking patterns or cause risk of harm or injury (e.g., topiramate, disulfiram, naltrexone, acetazolamide, stimulants such as amphetamine, or tramadol; * Schizophrenia, bipolar disorder, posttraumatic stress disorder (PTSD), or substantial suicide or violence risk (i.e., can't be managed safely in the outpatient setting) on the basis of history or psychiatric examination; j) currently dependent on opioids or benzodiazepines or other sedatives * Considered by the investigators to be clinically inappropriate for study participation or have participated in another pharmacotherapy study in the past thirty days * Subjects with prominent signs of physical dependence, and/or medical comorbidities such that study physicians feel they should consider immediate detoxification, and referred for medical detoxification in a normal treatment setting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drinks Per Week | over 8 weeks (weeks 9-16) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gamma Glutamyl Transferase (GGT) | Baseline, Week 4, 8 and 16 | 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 |
| Number of Heavy Drinking Days Per Week | over 16 weeks (weeks 1-16) | 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). |
| Percentage of Subjects With No Heavy Drinking Days (PSNHDD) | Baseline | Percentage of Subjects with No Heavy Drinking Days (PSNHDD) The PSNHDD can be derived from each subject's timeline follow back (TLFB) data. |
| Change in Quality of Life | Over 16 weeks (Baseline and 16 weeks) | 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. |
| Level of Alcohol-related Problems (SIP) | over 16 weeks (Baseline and Week 16) | 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. |
| Alcohol Urge Questionnaire Score (AUQ) | over 16 weeks (weeks 1-16) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Randomization was conducted by the pharmacy using a 1:1 randomization in blocks of 4 and stratified by site.
Participants by arm
| Arm | Count |
|---|---|
| Zonisamide Men or women veterans, ages 21-70, met Diagnostic and Statistical Manual IV Text Revision (DSM-IV) criteria for current Alcohol Dependence (AD) (determined by structured clinical interview) | 43 |
| Placebo Men or women veterans, ages 21-70, met Diagnostic and Statistical Manual IV Text Revision (DSM-IV) criteria for current Alcohol Dependence (AD) (determined by structured clinical interview) | 45 |
| Total | 88 |
Baseline characteristics
| Characteristic | Zonisamide | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 11.7 | 51.8 years STANDARD_DEVIATION 10.8 | 50.5 years STANDARD_DEVIATION 11.3 |
| Race/Ethnicity, Customized African American | 11 Participants | 11 Participants | 22 Participants |
| Race/Ethnicity, Customized Caucasian | 31 Participants | 31 Participants | 62 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 39 Participants | 42 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 2 / 46 | 6 / 46 |
| serious Total, serious adverse events | 4 / 46 | 0 / 46 |
Outcome results
Primary
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)
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zonisamide | Number of Drinks Per Week | Week 9 | 17.8 Number of total drinks | Standard Error 7.6 |
| Zonisamide | Number of Drinks Per Week | Week 10 | 12.2 Number of total drinks | Standard Error 4.6 |
| Zonisamide | Number of Drinks Per Week | Week 11 | 15.9 Number of total drinks | Standard Error 5.6 |
| Zonisamide | Number of Drinks Per Week | Week 12 | 10.3 Number of total drinks | Standard Error 3.6 |
| Zonisamide | Number of Drinks Per Week | Week 13 | 9.4 Number of total drinks | Standard Error 6.9 |
| Zonisamide | Number of Drinks Per Week | Week 14 | 9.9 Number of total drinks | Standard Error 3.4 |
| Zonisamide | Number of Drinks Per Week | Week 15 | 13.7 Number of total drinks | Standard Error 4.1 |
| Zonisamide | Number of Drinks Per Week | Week 16 | 11.1 Number of total drinks | Standard Error 5.1 |
| Placebo | Number of Drinks Per Week | Week 16 | 8.7 Number of total drinks | Standard Error 4.3 |
| Placebo | Number of Drinks Per Week | Week 9 | 8.1 Number of total drinks | Standard Error 7.5 |
| Placebo | Number of Drinks Per Week | Week 13 | 12.5 Number of total drinks | Standard Error 6.3 |
| Placebo | Number of Drinks Per Week | Week 10 | 8.8 Number of total drinks | Standard Error 4.5 |
| Placebo | Number of Drinks Per Week | Week 15 | 3.3 Number of total drinks | Standard Error 3.7 |
| Placebo | Number of Drinks Per Week | Week 11 | 3.6 Number of total drinks | Standard Error 5.5 |
| Placebo | Number of Drinks Per Week | Week 14 | 4.3 Number of total drinks | Standard Error 3.1 |
| Placebo | Number of Drinks Per Week | Week 12 | 6.2 Number of total drinks | Standard Error 3.6 |
Secondary
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)
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 9 | 13.4 units on a scale | Standard Error 1.2 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Baseline | 17.1 units on a scale | Standard Error 1.2 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 1 | 13.3 units on a scale | Standard Error 1.1 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 2 | 14.0 units on a scale | Standard Error 1.2 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 3 | 14.7 units on a scale | Standard Error 1.1 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 4 | 13.5 units on a scale | Standard Error 1 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 5 | 13.6 units on a scale | Standard Error 1.1 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 6 | 12.3 units on a scale | Standard Error 1.2 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 7 | 12.7 units on a scale | Standard Error 1.1 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 8 | 12.4 units on a scale | Standard Error 1.1 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 10 | 11.9 units on a scale | Standard Error 1 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 11 | 10.9 units on a scale | Standard Error 0.8 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 12 | 11.7 units on a scale | Standard Error 1 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 13 | 10.3 units on a scale | Standard Error 0.8 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 14 | 11.8 units on a scale | Standard Error 1.2 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 15 | 10.8 units on a scale | Standard Error 0.8 |
| Zonisamide | Alcohol Urge Questionnaire Score (AUQ) | Week 16 | 12.0 units on a scale | Standard Error 1 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 16 | 9.8 units on a scale | Standard Error 1 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 8 | 11.3 units on a scale | Standard Error 1.1 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Baseline | 14.8 units on a scale | Standard Error 1.2 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 9 | 11.0 units on a scale | Standard Error 1.2 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 1 | 12.7 units on a scale | Standard Error 1 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 13 | 10.3 units on a scale | Standard Error 0.8 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 2 | 11.8 units on a scale | Standard Error 1.2 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 10 | 10.7 units on a scale | Standard Error 0.9 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 3 | 10.7 units on a scale | Standard Error 1.1 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 15 | 9.7 units on a scale | Standard Error 0.8 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 4 | 10.7 units on a scale | Standard Error 1 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 11 | 10.9 units on a scale | Standard Error 0.8 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 5 | 10.7 units on a scale | Standard Error 1.1 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 14 | 9.8 units on a scale | Standard Error 1.2 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 6 | 10.7 units on a scale | Standard Error 1.2 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 12 | 10.3 units on a scale | Standard Error 0.9 |
| Placebo | Alcohol Urge Questionnaire Score (AUQ) | Week 7 | 12.1 units on a scale | Standard Error 1.1 |
Secondary
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)
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zonisamide | Change in Quality of Life | Baseline | 56.9 units on a scale | Standard Error 2.7 |
| Zonisamide | Change in Quality of Life | Week 16 | 73.3 units on a scale | Standard Error 3.5 |
| Placebo | Change in Quality of Life | Baseline | 55.8 units on a scale | Standard Error 2.6 |
| Placebo | Change in Quality of Life | Week 16 | 72.9 units on a scale | Standard Error 3.1 |
Secondary
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
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zonisamide | Gamma Glutamyl Transferase (GGT) | Baseline | 76.0 Units/Liter (U/L) | Standard Error 12.7 |
| Zonisamide | Gamma Glutamyl Transferase (GGT) | Week 4 | 63.4 Units/Liter (U/L) | Standard Error 8.8 |
| Zonisamide | Gamma Glutamyl Transferase (GGT) | Week 8 | 61.40 Units/Liter (U/L) | Standard Error 8.8 |
| Zonisamide | Gamma Glutamyl Transferase (GGT) | Week 16 | 62.8 Units/Liter (U/L) | Standard Error 10.2 |
| Placebo | Gamma Glutamyl Transferase (GGT) | Week 16 | 46.4 Units/Liter (U/L) | Standard Error 9.9 |
| Placebo | Gamma Glutamyl Transferase (GGT) | Baseline | 78.2 Units/Liter (U/L) | Standard Error 12.2 |
| Placebo | Gamma Glutamyl Transferase (GGT) | Week 8 | 45.5 Units/Liter (U/L) | Standard Error 8.7 |
| Placebo | Gamma Glutamyl Transferase (GGT) | Week 4 | 50.0 Units/Liter (U/L) | Standard Error 8.7 |
Secondary
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)
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zonisamide | Level of Alcohol-related Problems (SIP) | Baseline | 4.8 units on a scale | Standard Error 0.4 |
| Zonisamide | Level of Alcohol-related Problems (SIP) | Week 16 | 1.2 units on a scale | Standard Error 0.5 |
| Placebo | Level of Alcohol-related Problems (SIP) | Baseline | 5.3 units on a scale | Standard Error 0.4 |
| Placebo | Level of Alcohol-related Problems (SIP) | Week 16 | 1.9 units on a scale | Standard Error 0.5 |
Secondary
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)
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 1 | 1.1 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 2 | 0.9 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 3 | 0.8 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 4 | 1.1 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 5 | 0.8 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 6 | 0.8 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 7 | 0.8 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Weel 8 | 1.0 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 9 | 1.0 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 10 | 1.0 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 11 | 0.8 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 12 | 0.8 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 13 | 0.7 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 14 | 0.9 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 15 | 0.8 Number of heavy drinking days | Standard Error 0.3 |
| Zonisamide | Number of Heavy Drinking Days Per Week | Week 16 | 11.4 Number of heavy drinking days | Standard Error 3.1 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 16 | 6.5 Number of heavy drinking days | Standard Error 3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 1 | 0.6 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 9 | 0.5 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 2 | 0.9 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 13 | 0.3 Number of heavy drinking days | Standard Error 0.2 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 3 | 0.8 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 10 | 0.5 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 4 | 0.3 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 15 | 0.5 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 5 | 0.5 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 11 | 0.4 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 6 | 0.6 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 14 | 0.2 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 7 | 0.6 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Week 12 | 0.5 Number of heavy drinking days | Standard Error 0.3 |
| Placebo | Number of Heavy Drinking Days Per Week | Weel 8 | 0.5 Number of heavy drinking days | Standard Error 0.3 |
Secondary
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
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zonisamide | Percentage of Subjects With No Heavy Drinking Days (PSNHDD) | Participants with No Heavy Drinking Days | 16 Participants |
| Zonisamide | Percentage of Subjects With No Heavy Drinking Days (PSNHDD) | Participants with Heavy Drinking Day | 27 Participants |
| Placebo | Percentage of Subjects With No Heavy Drinking Days (PSNHDD) | Participants with No Heavy Drinking Days | 28 Participants |
| Placebo | Percentage of Subjects With No Heavy Drinking Days (PSNHDD) | Participants with Heavy Drinking Day | 18 Participants |