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Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00498628
First received: July 6, 2007
Last updated: August 8, 2014
Last verified: August 2014
Results First Received: April 25, 2012  
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
Interventions: Drug: Quetiapine fumarate
Other: 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
Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between December 2007 and May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
218 comprises the Modified Intent To Treat group (MITT)

Reporting Groups
  Description
Quetiapine Fumerate Plus Medical Management Quetiapine fumarate - target dose 400mg/day plus medical management
Sugar Pill Plus Medical Management Medical management plus placebo comparator

Participant Flow:   Overall Study
    Quetiapine Fumerate Plus Medical Management     Sugar Pill Plus Medical Management  
STARTED     105     113  
COMPLETED     90     92  
NOT COMPLETED     15     21  



  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
Quetiapine Fumerate Plus Medical Management Quetiapine fumarate - target dose 400mg/day plus medical management
Sugar Pill Plus Medical Management Medical management plus placebo comparator
Total Total of all reporting groups

Baseline Measures
    Quetiapine Fumerate Plus Medical Management     Sugar Pill Plus Medical Management     Total  
Number of Participants  
[units: participants]
  105     113     218  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     105     113     218  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.4  ± 9.3     45.5  ± 9.8     45.4  ± 9.4  
Gender  
[units: participants]
     
Female     17     26     43  
Male     88     87     175  
Region of Enrollment  
[units: participants]
     
United States     105     113     218  



  Outcome Measures

1.  Primary:   Percent Heavy Drinking Days   [ Time Frame: Weeks 3 - 11 ]

2.  Secondary:   Percent Days Abstinent   [ Time Frame: 3-11 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Drinks Per Drinking Day   [ Time Frame: 3-11 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Drinks Per Day   [ Time Frame: 3-11 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Percent Very Heavy Drinking Day   [ Time Frame: 3-11 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Percent Subjects Abstinent   [ Time Frame: 3-11 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Percent Subjects With no Heavy Drinking Day   [ Time Frame: 3-11 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Drinking Consequences Score   [ Time Frame: Weeks 6 and 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Craving Score   [ Time Frame: Week 4, 6, 8, 10, 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Depression Score   [ Time Frame: Week 4, 6, 8, 10, and 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Anxiety Score   [ Time Frame: Weeks 4, 6, 8, 10 and 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Sleep Quality Score   [ Time Frame: Weeks 4, 8 and 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Quality of Life Score   [ Time Frame: Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Dr. Raye Litten
Organization: NIAAA
phone: 301-443-0636


Publications of Results:

Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00498628     History of Changes
Other Study ID Numbers: NIAAA_DTRR-2007-LITTEN-01
Study First Received: July 6, 2007
Results First Received: April 25, 2012
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration