Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study

Alcoholism Clinical Trial

Official title: Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study

Status Completed

Clinical Trial Summary

Due to Quetiapine's particulars and the promising receptor profile, we want to examine the efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive symptoms, persisting anxiety symptoms) in comparison to matching placebo in a double-blind pilot study.

We further want to compare the course of the above mentioned craving and affective symptoms under medication with quetiapine / matching placebo.

Clinical Trial Description

Naltrexone and Acamprosate are the best evaluated and established therapy options in relapse prevention of alcoholics at present (Litten et al. 1996, Mann et al. 2004). Studies on cue exposure showed that Naltrexone (Monti et al. 1999) and Haloperidol (Modell et al. 1993) block stimuli triggered craving. In addition, they indicate that both may also stop the craving for further alcohol consumption that is induced by a priming dose of alcohol (Modell et al. 1993). However, the clinical relevance of Haloperidol is rather limited due to the risk of extrapyramidal side effects. New atypical dopamine antagonists are reported to have this profile as well, but without the risk of developing extrapyramidal side effects. In a placebo-controlled clinical trial, the atypical antipsychotic Olanzapine has proved to reduce craving for alcohol both after alcohol exposure and a priming dose of alcohol in non-dependent heavy social drinkers (Hutchison et al. 2001). However, Amisulpride in a dose of 50 mg per day failed to prevent alcohol relapse in a double-blind, placebo-controlled study in 71 patients over 6 months (Marra et al. 2002). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Consumption
• Alcohol Drinking
• Alcohol Relapse Prevention
• Alcoholism

• NCT number: NCT00561587
• Study type: Interventional
• Source: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Completion date: February 2010