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Alcohol Self Administration Laboratory

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398918
First Posted: November 14, 2006
Last Update Posted: July 14, 2017
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.
Information provided by (Responsible Party):
Boston University
Results First Submitted: February 8, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
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 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  70.0% 
Male      3  30.0% 
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


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


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



Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00398918     History of Changes
Other Study ID Numbers: H-25360
First Submitted: November 13, 2006
First Posted: November 14, 2006
Results First Submitted: February 8, 2010
Results First Posted: May 14, 2010
Last Update Posted: July 14, 2017