The Effects of Zonisamide on Alcohol Dependence

Phase 2

Completed

Brief Summary: In this study the influence of zonisamide administration over a 13 week period on alcohol consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of zonisamide given to subjects will be slowly increased over a period of several weeks. They will receive a full dose over a 5 week period. This will be a pilot study in which all of the subjects will only receive zonisamide. A primary objective of this study is to determine the possible size of the effect that zonisamide administration has on drinking (i.e. drinks consumed per day) to allow us to plan for a larger clinical trial of the effects of zonisamide on alcohol dependence.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Zonisamide	Zonisamide	In open-label non-placebo controlled trial subjects are treatment with zonisamide 400 mg during the maintenance phase of this study

Primary Outcome Measures

Name	Time	Method
The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase	Baseline and Week 12	The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.
Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).	Week 0- Baseline and Week 12	Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.

Secondary Outcome Measures

Name	Time	Method
Symbol Digit Modalities Test (DSMT)	Baseline, Week 12	Number of correct digit substitutions on the DSMT per session with the possible maximum score being 188. The value shown is for difference between mean scores obtained for baseline and week 12 sessions.