title: A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients.
abstract: 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.
authors.affiliation: Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland 20892, USA.
authors.forename: Raye Z
authors.initials: RZ
authors.lastname: Litten
authors.forename: Joanne B
authors.initials: JB
authors.lastname: Fertig
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Falk
authors.forename: Megan L
authors.initials: ML
authors.lastname: Ryan
authors.forename: Margaret E
authors.initials: ME
authors.lastname: Mattson
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Collins
authors.forename: Cristin
authors.initials: C
authors.lastname: Murtaugh
authors.forename: Domenic
authors.initials: D
authors.lastname: Ciraulo
authors.forename: Alan I
authors.initials: AI
authors.lastname: Green
authors.forename: Bankole
authors.initials: B
authors.lastname: Johnson
authors.forename: Helen
authors.initials: H
authors.lastname: Pettinati
authors.forename: Robert
authors.initials: R
authors.lastname: Swift
authors.forename: Maryam
authors.initials: M
authors.lastname: Afshar
authors.forename: Mary F
authors.initials: MF
authors.lastname: Brunette
authors.forename: Nassima A-D
authors.initials: NA
authors.lastname: Tiouririne
authors.forename: Kyle
authors.initials: K
authors.lastname: Kampman
authors.forename: Robert
authors.initials: R
authors.lastname: Stout
mesh_terms: D000293:Adolescent; D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy*; D000437:Alcoholism / Q000188:drug therapy*; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000150:complications / Q000188:drug therapy; D003692:Delayed-Action Preparations / Q000627:therapeutic use*; D003863:Depression / Q000150:complications / Q000188:drug therapy; D003987:Dibenzothiazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011788:Quality of Life; D000069348:Quetiapine Fumarate; D012890:Sleep / Q000187:drug effects
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate