title: A double-blind, placebo-controlled, randomized pilot study comparing quetiapine with placebo, associated to naltrexone, in the treatment of alcohol-dependent patients.
abstract: 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.
authors.affiliation: Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. jguardia@santpau.cat
authors.forename: Josep
authors.initials: J
authors.lastname: Guardia
authors.forename: Carlos
authors.initials: C
authors.lastname: Roncero
authors.forename: Jaime
authors.initials: J
authors.lastname: Galan
authors.forename: Begoña
authors.initials: B
authors.lastname: Gonzalvo
authors.forename: Teresa
authors.initials: T
authors.lastname: Burguete
authors.forename: Miquel
authors.initials: M
authors.lastname: Casas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000437:Alcoholism / Q000188:drug therapy*; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D003987:Dibenzothiazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D010045:Outpatients; D010865:Pilot Projects; D000069348:Quetiapine Fumarate; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D009292:Narcotic Antagonists; D000069348:Quetiapine Fumarate; D009271:Naltrexone