A double-blind, placebo-controlled trial to assess the efficacy of quetiapine
fumarate XR in very heavy-drinking alcohol-dependent patients.
Author(s): Litten RZ, Fertig JB, Falk DE, Ryan ML, Mattson ME, Collins JF, Murtaugh C,
Ciraulo D, Green AI, Johnson B, Pettinati H, Swift R, Afshar M, Brunette MF,
Tiouririne NA, Kampman K, Stout R; NCIG 001 Study Group.
Collaborators: Biondolillo MJ, Colaneri LS, Devine EG, Gugliotta J, Knapp CM,
Putnam MA, Richambault CA, Sarid-Segal O, Streeter CC, Waters ME, Beitler B,
Biddle J, Clarke C, Sharkoski T, Sorensen L, Dundon WD, Griffin-Farraday K,
Hendrickson M, Kirchner K, Kaempf G, Jenkins-Mendoza E, Sembrowich S, Kenna G,
Leggio L, Kern A, O'Keefe C, Rondeau S.
Affiliation(s): Division of Treatment and Recovery Research, National Institute on Alcohol Abuse
and Alcoholism, Bethesda, Maryland 20892, USA.
Publication date & source: 2012, Alcohol Clin Exp Res. , 36(3):406-16
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.
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