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A Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of Quetiapine Fumarate XR in Very Heavy-Drinking Alcohol-Dependent Patients

Background:  Despite advances in developing medications to treat alcohol dependence, few such medications have been approved by the Food and Drug Administration. Identified molecular targets are encouraging and can lead to the development and testing of new compounds. Atypical antipsychotic medicati...

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Published in:Alcoholism, clinical and experimental research clinical and experimental research, 2012-03, Vol.36 (3), p.406-416
Main Authors: Litten, Raye Z., Fertig, Joanne B., Falk, Daniel E., Ryan, Megan L., Mattson, Margaret E., Collins, Joseph F., Murtaugh, Cristin, Ciraulo, Domenic, Green, Alan I., Johnson, Bankole, Pettinati, Helen, Swift, Robert, Afshar, Maryam, Brunette, Mary F., Tiouririne, Nassima A.-D., Kampman, Kyle, Stout, Robert
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Language:English
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Summary:Background:  Despite advances in developing medications to treat alcohol dependence, few such medications have been approved by the Food and Drug Administration. Identified molecular targets are encouraging and can lead to the development and testing of new compounds. Atypical antipsychotic medications have been explored with varying results. Prior research suggests that the antipsychotic quetiapine may be beneficial in an alcohol‐dependent population of very heavy drinkers. Methods:  In this double‐blind, placebo‐controlled trial, 224 alcohol‐dependent patients who reported very heavy drinking were recruited across 5 clinical sites. Patients received either quetiapine or placebo and Medical Management behavioral intervention. Patients were stratified on gender, clinical site, and reduction in drinking prior to randomization. Results:  No differences between the quetiapine and placebo groups were detected in the primary outcome, percentage heavy‐drinking days, or other drinking outcomes. Quetiapine significantly reduced depressive symptoms and improved sleep but had no effect on other nondrinking outcomes. Results from a subgroup analysis suggest that patients who reduced their drinking prior to randomization had significantly better drinking outcomes during the maintenance phase (p 
ISSN:0145-6008
1530-0277
DOI:10.1111/j.1530-0277.2011.01649.x