The Effects of Zonisamide on Alcohol Dependence
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of Zonisamide on Alcohol Dependence|
- The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]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). [ Time Frame: Week 0- Baseline and Week 12 ] [ Designated as safety issue: Yes ]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.
- Symbol Digit Modalities Test (DSMT) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
In open-label non-placebo controlled trial subjects are treatment with zonisamide 400 mg during the maintenance phase of this study
Week 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406692
|United States, Massachusetts|
|Boston University School of Medicine|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Clifford Knapp, PhD||Boston University|