The Effects of Zonisamide on Alcohol Dependence
|ClinicalTrials.gov Identifier: NCT00406692|
Recruitment Status : Completed
First Posted : December 4, 2006
Results First Posted : May 6, 2010
Last Update Posted : May 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: Zonisamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Zonisamide on Alcohol Dependence|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||November 2009|
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.
- The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase [ Time Frame: 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). [ Time Frame: 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.
- Symbol Digit Modalities Test (DSMT) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406692
|United States, Massachusetts|
|Boston University School of Medicine|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Clifford Knapp, PhD||Boston University|