A Phase 4 interventional study of zonisamide and Placebo in Alcoholism, Alcohol Abuse and Alcohol Dependence, sponsored by UConn Health. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-10-15.
Sponsored by UConn Health · Phase 4, Interventional, and Treatment
This is a pilot study designed to examine the potential efficacy and tolerability of zonisamide compared to placebo for the treatment of alcohol dependence.
Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and easier to titrate in the outpatient setting than topiramate, it may offer important clinical advantages in the treatment of alcoholism.
This is a small 12-week placebo-controlled pilot study examining tolerability and potential efficacy in anticipation of a larger, placebo-controlled trial of zonisamide for treatment of alcohol dependence. It is a randomized, double-blind trial of zonisamide vs. placebo at flexible dosages of 100-500mg/day in alcoholics receiving ambulatory psychosocial treatment. Participants will take part in six individual Cognitive-Behavioral based therapy sessions, which are focused on learning coping skills. Participants must endorse a goal of either cutting down their drinking to non-hazardous levels, or abstinence.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 40 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →UConn Health is the lead sponsor of 182 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
have 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 greater than 300% of the uper limit of normal or direct bilirubin levels 150% of the upper limit of normal) on the basis of medical history, physician examination, or routine laboratory evaluation. Serum creatinine level of > 1.2 mg/dl will also be exclusionary. Other specific exclusionary disorders include:
Zonisamide
Drug: zonisamide
placebo
Drug: Placebo
flexible dosages of 100-500mg/day
Also known as: Zonegran
Placebo
Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week
This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).
Time frame: baseline to the end of 12 weeks in treatment
Weekly Rate of Change in Abstinent Days
This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).
Time frame: baseline to the end of 12 weeks in treatment
Change in Number of Drinks Per Week by Week
This outcome measure represents the change in the total number of standard drinks per week (weekly data) from baseline to the end of week twelve. This was analyzed using weekly measurements from baseline to week 12 week of the study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).
Time frame: baseline to the end of 12 weeks in treatment
Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)
This is the change in measured urge to drink alcohol as measured by the Alcohol Urge Questionnaire (AUQ), measured every 2 weeks from baseline until the last week of the study (over twelve weeks, 7 timepoint measurements of AUQ, 6 calculated changes). It is reported in terms of change per visit (every 2 weeks). AUQ measures a feeling state, and uses a 7 point (1-7)Likert scale for each of 8 items (questions). The lowest urge score is 8 (representing less urge to drink), and the highest would be tabulated as 56 (meaning more urge to drink). Repeated measures SPPS linear mixed models used.
Time frame: baseline to the end of 12 weeks in treatment
Change in Gamma-glutamyl Transferase (GGT) Concentration
This outcome measure looks at the change in blood levels of this enzyme assay from baseline, and then after 6 weeks (midpoint), and then at the endpoint (12 weeks). The analysis takes into account all three time points, and reports the average change between each of the three time points.
Time frame: 12 weeks (from initiation to end of treatment)
| Milestone | Zonisamide Medication Treatment | Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 17 | 19 |
| Not completed | 3 | 1 |
This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).
| Days/week | Zonisamide Medication Treatment | Placebo |
|---|---|---|
| Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week | -.30 ± .362 | -.20 ± .362 |
This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).
| days/week | Zonisamide Medication Treatment | Placebo |
|---|---|---|
| Weekly Rate of Change in Abstinent Days | 0.17 ± .02 | 0.13 ± .02 |
This outcome measure represents the change in the total number of standard drinks per week (weekly data) from baseline to the end of week twelve. This was analyzed using weekly measurements from baseline to week 12 week of the study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).
| drinks/week | Zonisamide Medication Treatment | Placebo |
|---|---|---|
| Change in Number of Drinks Per Week by Week | -2.2 ± 20.5 | -1.4 ± 20.5 |
This is the change in measured urge to drink alcohol as measured by the Alcohol Urge Questionnaire (AUQ), measured every 2 weeks from baseline until the last week of the study (over twelve weeks, 7 timepoint measurements of AUQ, 6 calculated changes). It is reported in terms of change per visit (every 2 weeks). AUQ measures a feeling state, and uses a 7 point (1-7)Likert scale for each of 8 items (questions). The lowest urge score is 8 (representing less urge to drink), and the highest would be tabulated as 56 (meaning more urge to drink). Repeated measures SPPS linear mixed models used.
| units on a scale/visit | Zonisamide Medication Treatment | Placebo |
|---|---|---|
| Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ) | -1.4 ± 1 | -0.6 ± 1 |
This outcome measure looks at the change in blood levels of this enzyme assay from baseline, and then after 6 weeks (midpoint), and then at the endpoint (12 weeks). The analysis takes into account all three time points, and reports the average change between each of the three time points.
| Units/Liter | Zonisamide Medication Treatment | Placebo |
|---|---|---|
| Change in Gamma-glutamyl Transferase (GGT) Concentration | 8.4 ± 36.2 | 2.9 ± 36.2 |
Collected over 14 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zonisamide Medication Treatment | — | 0/20 (0%) | 16/20 (80%) |
| Placebo | — | 0/20 (0%) | 16/20 (80%) |
| Event | Zonisamide Medication Treatment | Placebo |
|---|---|---|
| GIGastrointestinal disorders | 13/20 | 4/20 |
| NeurologicNervous system disorders | 8/20 | 5/20 |
| PsychiatricPsychiatric disorders | 4/20 | 8/20 |
| CognitiveNervous system disorders | 4/20 | 2/20 |
| GenitourinaryReproductive system and breast disorders | 4/20 | 2/20 |
| Fatigue/SomnolenceGeneral disorders | 4/20 | 1/20 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 2/20 | 2/20 |
| Age, Categorical(Participants) | Zonisamide Medication Treatment | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 20 | 40 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Zonisamide Medication Treatment | Placebo | Total |
|---|---|---|---|
| Mean | 47.8 ± 9.9 | 50.4 ± 11 | 49.1 ± 10 |
| Sex: Female, Male(Participants) | Zonisamide Medication Treatment | Placebo | Total |
|---|---|---|---|
| Female | 8 | 9 | 17 |
| Male | 12 | 11 | 23 |
| Region of Enrollment(participants) | Zonisamide Medication Treatment | Placebo | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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