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Levetiracetam XR in Very Heavy Drinkers (NCIG 002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00970814
First received: September 1, 2009
Last updated: August 20, 2014
Last verified: August 2014
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Behavioral: BBCET
Drug: Levetiracetam XR
Drug: Sugar Pill

  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
Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between November 2009 and May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Must be alcohol dependent (DSM-IV criteria); and drinking very heavily (10 or more drinks/drinking day men; 8 or more drinks /drinking day women) 40% of the days during any consecutive 60-day interval during the 90-day period before the clinic screening visit, with at least 1 heavy drinking day occurring within the 14 days before randomization.

Reporting Groups
  Description
Sugar Pill and BBCET Placebo and Brief Behavioral Compliance Enhancement Therapy
Levetiracetam and BBCET Levetiracetam and Brief Behavioral Therapy

Participant Flow:   Overall Study
    Sugar Pill and BBCET     Levetiracetam and BBCET  
STARTED     66     64  
COMPLETED     58     50  
NOT COMPLETED     8     14  



  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
Sugar Pill and BBCET Placebo and Brief Behavioral Compliance Enhancement Therapy
Levetiracetam and BBCET Levetiracetam and Brief Behavioral Therapy
Total Total of all reporting groups

Baseline Measures
    Sugar Pill and BBCET     Levetiracetam and BBCET     Total  
Number of Participants  
[units: participants]
  66     64     130  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     66     64     130  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47  ± 11.5     41.7  ± 11.7     44  ± 11.9  
Gender  
[units: participants]
     
Female     14     17     31  
Male     52     47     99  
Region of Enrollment  
[units: participants]
     
United States     66     64     130  



  Outcome Measures
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1.  Primary:   The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.   [ Time Frame: Weeks 5-14 ]

2.  Primary:   The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.   [ Time Frame: Study Weeks 5-14 ]

3.  Secondary:   The Number of Drinks Per Drinking Day Study Weeks 5-14.   [ Time Frame: Study Weeks 5-14 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Megan Ryan - Clinical Trials Project Manager
Organization: NIAAA
phone: 301-443-4225
e-mail: mryan1@mail.nih.gov


Publications of Results:

Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00970814     History of Changes
Other Study ID Numbers: NIAAA_DTRR-2009-LITTEN-02
Study First Received: September 1, 2009
Results First Received: April 26, 2012
Last Updated: August 20, 2014
Health Authority: United States: Federal Government