A double-blind, placebo-controlled, randomized pilot study comparing quetiapine
with placebo, associated to naltrexone, in the treatment of alcohol-dependent
patients.
Author(s): Guardia J, Roncero C, Galan J, Gonzalvo B, Burguete T, Casas M.
Affiliation(s): Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
jguardia@santpau.cat
Publication date & source: 2011, Addict Behav. , 36(3):265-9
The objective of this study was to determine whether quetiapine plus naltrexone
is more effective than naltrexone alone for the treatment of alcohol-dependent
patients. This was a double-blind, randomized clinical trial where eligible
alcohol-dependent patients were randomized to receive naltrexone (50mg/day) plus
quetiapine (25-200mg/day) or naltrexone (50mg/day) plus placebo for 12 weeks, and
afterwards patients received naltrexone alone during 4 additional weeks. The
primary efficacy measures were percent days abstinent, drinks per drinking day,
and the relapse rate. Sixty-two patients received a single-blind treatment with
placebo plus naltrexone, and they were thereafter randomly assigned to quetiapine
plus naltrexone (n=30) or placebo plus naltrexone (n=32). Eleven (36.7%) patients
in the quetiapine-treated group and 4 (12.5%) patients in the placebo-treated
group withdrew before they completed 12 weeks of treatment. There were no
statistically significant differences for any primary drinking outcomes between
treatment groups. Both regimens were well tolerated. This study failed to
demonstrate any additional benefit from the combination of quetiapine and
naltrexone compared to naltrexone alone on drinking outcomes.
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