NCT00561587

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

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

Interventions

Type	Name	Description
DRUG	Seroquel®	dosage form: oral, adjusted in the range of 25 to max. 300 mg /day

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-08-01
• Completion: 2010-02-01
• First posted: 2007-11-21
• Last updated: 2011-04-18

Locations

1 site across 1 country: Germany