P03-199 - RCT: Quetiapine vs. placebo in alcohol relapse prevention. Rational, methods and preliminary results

Abstract

IntroductionQuetiapine is a novel antipsychotic drug, which is efficacious in the treatment of schizophrenia and also helps reduce craving and consumption of stimulants and alcohol. Due to Quetiapine's promising receptor profile, we set out to examine its efficacy in relapse prevention treatment of alcoholic dependent patients suffering from craving and affective symptoms.MethodsThe three center pilot-RCT evaluated 40 alcohol dependent patients after withdrawal (Quetiapine vs. placebo). They were followed up for six months. We used operationalized questionnaires including OCDS-G, Form 90-CR, Form 90 short form-CR, PSQI, MADRS, STAI, BDI and FTND.HypothesesWe tested the one sided hypothesis that it takes longer for the first severe relapse to occur using Quetiapine compared to a placebo. The primary outcome measure is time to first severe relapse. Further, we tested the two sided hypothesis that Quetiapine will prolong time until first consumption of ethanol, decrease the number of drinking days and increase the number of abstinence days, decrease the cumulative amount of ethanol, decrease craving, improve depression symptoms, improve anxiety symptoms, improve quality of sleep, avoid deterioration of safety variables and decrease nicotine addiction.ConclusionOur pilot study is designed to provide evidence for the efficacy of Quetiapine in alcohol relapse prevention. Alcohol dependent patients after withdrawal should display a decrease in persistant craving and should be less afflicted by sleep disorders, excitement or symptoms of depression or anxiety. The poster provides the rational for conducting this study and describes the study protocol including the subject's characteristics.