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Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

This study has been completed.
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Center for Research Resources (NCRR)
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00595556
First received: January 6, 2008
Last updated: September 28, 2010
Last verified: September 2010
History of Changes
Results First Received: May 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Alcoholism
Alcohol Abuse
Alcohol Dependence
Interventions: Drug: zonisamide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Zonisamide Medication Treatment     Placebo  
STARTED     20     20  
COMPLETED     17     19  
NOT COMPLETED     3     1  



  Baseline Characteristics
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
 		  20     20     40  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  47.8  ± 9.9     50.4  ± 11     49.1  ± 10  
Gender  
[units: participants]
 		     
Female     8     9     17  
Male     12     11     23  
Region of Enrollment  
[units: participants]
 		     
United States     20     20     40  



  Outcome Measures
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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 ]
  Show Outcome Measure 1

2.  Primary:   Weekly Rate of Change in Abstinent Days   [ Time Frame: baseline to the end of 12 weeks in treatment ]
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3.  Secondary:   Change in Number of Drinks Per Week by Week   [ Time Frame: baseline to the end of 12 weeks in treatment ]
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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 ]
  Show Outcome Measure 4

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Albert J. Arias, M.D.
Organization: UCHC
phone: 8606794423 ext 4423
e-mail: alarias@uchc.edu


No publications provided


Responsible Party: Albert J. Arias, MD, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00595556     History of Changes
Other Study ID Numbers: 06-113-1, P50 AA03510, M01RR006192
Study First Received: January 6, 2008
Results First Received: May 15, 2010
Last Updated: September 28, 2010
Health Authority: United States: Institutional Review Board