Eficacia de tiapride en el mantenimiento de la abstinencia en alcohólicos desintoxicados. Resultados de un ensayo clínico a doble ciego frente a placebo

Abstract

Introduction: Tiapride has been proposed as an adjunct in pharmacological treatment in the postweaning phase of alcoholism treatment, as well as in the detoxification period. This trial attempts to test its efficacy in a sample of alcoholics in Spain. Material and method: 81 detoxified alcoholics from 4 different centres and with a clinical diagnosis of alcohol dependence (DSM III-R), were randomly allocated to the experimental (tiapride, n = 38) and control (placebo, n = 43) groups. All patients were given tiapride 100 mg (or matching placebo tablets), to be taken every 8 hours for 24 weeks. 11 controls were scheduled and blood samples were collected on weeks 8, 16 and 24. Statistical analysis was performed under the ITT principle, and Time to first Relapse (TFR) and Cumulated Abstinence Duration (CAD) were used as the main outcome measures. Results: No significant differences were found between both samples in terms of sociodemographic variables, clinical characteristics of alcohol dependence and biological markers of alcoholism. Attrition rates were slightly higher in the placebo group (18% versus 35%) without reaching statistical significance (p>.09). At the 6 months follow up, 49% patients in the placebo group and 37% in the tiapride group were still abstinent, with a mean TFR of 97 versus 88 days in favour of the placebo group (p