Alcohol Self Administration Laboratory

This study has been completed.
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00398918
First received: November 13, 2006
Last updated: April 27, 2010
Last verified: April 2010
Results First Received: February 8, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Alcoholism
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
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Reporting Groups
  Description
Zonisamide-Placebo Sessions In this within subjects study, subjects received zonisamide in one session and placebo in a second

Participant Flow:   Overall Study
    Zonisamide-Placebo Sessions  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Zonisamide-Placebo Sessions In this within subjects study, subjects received zonisamide in one session and placebo in a second

Baseline Measures
    Zonisamide-Placebo Sessions  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Gender  
[units: participants]
 
Female     7  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions   [ Time Frame: 1 day ]

2.  Secondary:   Score Digit Symbol Modalities Test   [ Time Frame: 40 minutes post alcohol ingestion ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: Ofra Sarid-Segal, MD
Organization: Boston University
phone: 617-414-1990
e-mail: ofra.segal@bmc.org


No publications provided


Responsible Party: Ofra Sarid-Segal, MD, Boston University
ClinicalTrials.gov Identifier: NCT00398918     History of Changes
Other Study ID Numbers: H-25360
Study First Received: November 13, 2006
Results First Received: February 8, 2010
Last Updated: April 27, 2010
Health Authority: United States: Institutional Review Board