Zonisamide vs. Placebo in the Treatment of 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. Identifier: NCT00595556
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : October 15, 2010
Last Update Posted : October 15, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Center for Research Resources (NCRR)
Information provided by:
UConn Health

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Alcoholism
Alcohol Abuse
Alcohol Dependence
Interventions: Drug: zonisamide
Drug: Placebo

  Participant Flow

  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.
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Reporting Groups
Zonisamide Medication Treatment Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
Placebo Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.
Total Total of all reporting groups

Baseline Measures
   Zonisamide Medication Treatment   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   20   20   40 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 47.8  (9.9)   50.4  (11)   49.1  (10) 
[Units: Participants]
Female   8   9   17 
Male   12   11   23 
Region of Enrollment 
[Units: Participants]
United States   20   20   40 

  Outcome Measures

1.  Primary:   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   [ Time Frame: baseline to the end of 12 weeks in treatment ]

2.  Primary:   Weekly Rate of Change in Abstinent Days   [ Time Frame: baseline to the end of 12 weeks in treatment ]

3.  Secondary:   Change in Number of Drinks Per Week by Week   [ Time Frame: baseline to the end of 12 weeks in treatment ]

4.  Secondary:   Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)   [ Time Frame: baseline to the end of 12 weeks in treatment ]

5.  Secondary:   Change in Gamma-glutamyl Transferase (GGT) Concentration   [ Time Frame: 12 weeks (from initiation to end of treatment) ]

  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
The small sample size and the short duration of treatment are limitations. High rates of retention in the treatment and adherence to the medication regimen are strengths. The concomitant psychotherapy may have caused a ceiling effect on medication.

  More Information

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

Results Point of Contact:  
Name/Title: Albert J. Arias, M.D.
Organization: UCHC
phone: 8606794423 ext 4423

Responsible Party: Albert J. Arias, MD, University of Connecticut Health Center Identifier: NCT00595556     History of Changes
Other Study ID Numbers: 06-113-1
P50AA003510 ( U.S. NIH Grant/Contract )
M01RR006192 ( U.S. NIH Grant/Contract )
First Submitted: January 6, 2008
First Posted: January 16, 2008
Results First Submitted: May 15, 2010
Results First Posted: October 15, 2010
Last Update Posted: October 15, 2010