Document Detail

A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients.
MedLine Citation:
PMID:  21950727     Owner:  NLM     Status:  MEDLINE    
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 < 0.0001). No significant interactions, however, were observed between reducer status and treatment group. Finally, quetiapine was generally well tolerated. Statistically significant adverse events that were more common with quetiapine versus placebo include dizziness (14 vs. 4%), dry mouth (32 vs. 9%), dyspepsia (13 vs. 2%), increased appetite (11 vs. 1%), sedation (15 vs. 3%), and somnolence (34 vs. 9%).
CONCLUSIONS: This multisite clinical trial showed no efficacy for quetiapine compared with placebo at reducing alcohol consumption in heavy-drinking alcohol-dependent patients.
Raye Z Litten; Joanne B Fertig; Daniel E Falk; Megan L Ryan; Margaret E Mattson; Joseph F Collins; Cristin Murtaugh; Domenic Ciraulo; Alan I Green; Bankole Johnson; Helen Pettinati; Robert Swift; Maryam Afshar; Mary F Brunette; Nassima A-D Tiouririne; Kyle Kampman; Robert Stout;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.     Date:  2011-09-26
Journal Detail:
Title:  Alcoholism, clinical and experimental research     Volume:  36     ISSN:  1530-0277     ISO Abbreviation:  Alcohol. Clin. Exp. Res.     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-02-24     Completed Date:  2012-06-22     Revised Date:  2013-06-27    
Medline Journal Info:
Nlm Unique ID:  7707242     Medline TA:  Alcohol Clin Exp Res     Country:  England    
Other Details:
Languages:  eng     Pagination:  406-16     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 by the Research Society on Alcoholism.
Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland 20892, USA.
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MeSH Terms
Alcohol Drinking / drug therapy*
Alcoholism / drug therapy*
Antipsychotic Agents / administration & dosage,  adverse effects,  therapeutic use*
Anxiety / complications,  drug therapy
Delayed-Action Preparations / therapeutic use*
Depression / complications,  drug therapy
Dibenzothiazepines / administration & dosage,  adverse effects,  therapeutic use*
Double-Blind Method
Middle Aged
Psychiatric Status Rating Scales / statistics & numerical data
Quality of Life
Sleep / drug effects
Grant Support
Reg. No./Substance:
0/Antipsychotic Agents; 0/Delayed-Action Preparations; 0/Dibenzothiazepines; BGL0JSY5SI/quetiapine
Matthew J Biondolillo / ; Laurie Sickles Colaneri / ; Eric G Devine / ; Joseph Gugliotta / ; Clifford M Knapp / ; Megan A Putnam / ; Courtney A Richambault / ; Orfa Sarid-Segal / ; Chris C Streeter / ; Megan E Waters / ; Brenda Beitler / ; Janice Biddle / ; Cynthia Clarke / ; Tiffany Sharkoski / ; Laura Sorensen / ; William D Dundon / ; Kelly Griffin-Farraday / ; Margo Hendrickson / ; Kathleen Kirchner / ; Gail Kaempf / ; Eva Jenkins-Mendoza / ; Sean Sembrowich / ; George Kenna / ; Lorenzo Leggio / ; Audrey Kern / ; Christopher O'Keefe / ; Shannon Rondeau /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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