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The Effects of Zonisamide on Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00406692
Recruitment Status : Completed
First Posted : December 4, 2006
Results First Posted : May 6, 2010
Last Update Posted : May 11, 2010
Information provided by:
Boston University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Alcoholism
Intervention: Drug: Zonisamide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period for this study was from May 2007 to April 2008. The primary forms of recruitment were newspaper advertisement and radio advertisement.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Zonisamide 400 mg daily

Participant Flow:   Overall Study
Withdrawal by Subject                4 
Physician Decision                1 
Adverse Event                1 
Lack of Efficacy                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Zonisamide 400 mg daily

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   16 
>=65 years   0 
[Units: Participants]
Female   3 
Male   13 
Region of Enrollment 
[Units: Participants]
United States   16 

  Outcome Measures

1.  Primary:   The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).   [ Time Frame: Week 0- Baseline and Week 12 ]

3.  Secondary:   Symbol Digit Modalities Test (DSMT)   [ Time Frame: Baseline, Week 12 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of this trial include lack of a placebo controlled arm and small sample size.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Clifford Knapp, PhD
Organization: Boston University
phone: 617-414-1990
e-mail: cknapp@bu.edu

Responsible Party: Clifford Knapp, PhD, Boston University
ClinicalTrials.gov Identifier: NCT00406692     History of Changes
Other Study ID Numbers: H-25544
First Submitted: November 30, 2006
First Posted: December 4, 2006
Results First Submitted: February 8, 2010
Results First Posted: May 6, 2010
Last Update Posted: May 11, 2010