Alcoholism Clinical Trial
Official title:
Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study
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.
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). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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