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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
Author(s) -
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
Publication year - 2012
Publication title -
alcoholism: clinical and experimental research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.267
H-Index - 153
eISSN - 1530-0277
pISSN - 0145-6008
DOI - 10.1111/j.1530-0277.2011.01649.x
Subject(s) - quetiapine , placebo , quetiapine fumarate , atypical antipsychotic , medicine , population , craving , adverse effect , randomization , somnolence , antipsychotic , psychiatry , randomized controlled trial , anesthesia , schizophrenia (object oriented programming) , addiction , alternative medicine , environmental health , pathology
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.