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Levetiracetam XR in Very Heavy Drinkers (NCIG 002)

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.
ClinicalTrials.gov Identifier: NCT00970814
Recruitment Status : Completed
First Posted : September 2, 2009
Results First Posted : July 6, 2012
Last Update Posted : August 28, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Behavioral: BBCET
Drug: Levetiracetam XR
Drug: Sugar Pill

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 66   64   130 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   66   64   130 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 47  (11.5)   41.7  (11.7)   44  (11.9) 
[Units: Participants]
Female   14   17   31 
Male   52   47   99 
Region of Enrollment 
[Units: Participants]
United States   66   64   130 

  Outcome Measures

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

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.

  More Information

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
First Submitted: September 1, 2009
First Posted: September 2, 2009
Results First Submitted: April 26, 2012
Results First Posted: July 6, 2012
Last Update Posted: August 28, 2014