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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:
UConn Health
ClinicalTrials.gov Identifier:
NCT00595556
First received: January 6, 2008
Last updated: September 28, 2010
Last verified: September 2010
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
No text entered.

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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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
  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 
Overall Participants Analyzed 
[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 ]

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
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Time Frame 14 weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0  

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.

Other Adverse Events
    Zonisamide Medication Treatment   Placebo
Total, other (not including serious) adverse events     
# participants affected / at risk   16/20 (80.00%)   16/20 (80.00%) 
Gastrointestinal disorders     
GI †     
# participants affected / at risk   13/20 (65.00%)   4/20 (20.00%) 
# events   16   5 
General disorders     
Fatigue/Somnolence †     
# participants affected / at risk   4/20 (20.00%)   1/20 (5.00%) 
# events   6   1 
Musculoskeletal and connective tissue disorders     
Musculoskeletal †     
# participants affected / at risk   2/20 (10.00%)   2/20 (10.00%) 
# events   2   2 
Nervous system disorders     
Neurologic †     
# participants affected / at risk   8/20 (40.00%)   5/20 (25.00%) 
# events   10   5 
Cognitive †     
# participants affected / at risk   4/20 (20.00%)   2/20 (10.00%) 
# events   4   2 
Psychiatric disorders     
Psychiatric †     
# participants affected / at risk   4/20 (20.00%)   8/20 (40.00%) 
# events   4   14 
Reproductive system and breast disorders     
Genitourinary †     
# participants affected / at risk   4/20 (20.00%)   2/20 (10.00%) 
# events   4   2 
Events were collected by systematic assessment



  Limitations and Caveats
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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.


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