Quetiapine Fumarate (Seroquel) for the Treatment of Alcohol Dependence.
The purpose of this study is to determine whether seroquel is effective in the treatment of type A and type B alcohol dependence.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Study of Quetiapine Fumarate (Seroquel) for the Treatment of Type A vs.Type B Alcoholics.|
- TLFB (TimeLine FollowBack) for 1) proportion of days abstinent; 2) proportion of days of heavy drinking; 3) time to the return of heavy drinking (drinking heavily for 2 out of 30 days). [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- 1. Patient acceptability of the pharmacotherapy (measured by treatment drop outs and pill noncompliance) 2. Changes in craving for alcohol over the course of treatment 3. Changes in any mood and anxiety symptoms over the course of treatment [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Study Completion Date:||October 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
|Experimental: Type A SERO||
|Experimental: Type B SERO||
|Placebo Comparator: Type A PLA||
|Placebo Comparator: Type B PLA||
The purpose of this study is to obtain preliminary data regarding the safety, efficacy and tolerability of quetiapine [Seroquel (SQL)] in treating Type A vs B alcohol dependent outpatients seeking treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124059
|United States, Pennsylvania|
|University of Pennsylvania Treatment Research Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Helen M Pettinati, PhD||University of Pennsylvania Treatment Research Center|