EPA-1800 – Efficacy and tolerability of oral caffeine with or without biperiden for cocaine detoxification in an inpatient setting: a double blind, randomized, placebo-controlled clinical trial

Purpose The aim of this study was to test the efficacy of caffeine with or without biperiden in the treatment of cocaine dependent patients. Methods A randomized, double blind, placebo-controlled clinical trial has been carried out in an inpatient regime during up to 13 days. Eligible patients were randomized to caffeine plus biperiden or caffeine plus biperiden placebo or caffeine placebo plus biperiden placebo. Findings Eighty five treatment-seeking patients were enrolled in this study. Patients were stabilized with a mean caffeine dose up to 15 mg/Kg. Results show that all three treatments are well tolerated and a clear reduction in cocaine withdrawal and craving was observed. Nevertheless, no statistically significant differences were found between groups in any outcome. Conclusion This study shows that inpatient cocaine detoxification with high caffeine doses, with or without biperiden, is well tolerated and allows further research on the usefulness of caffeine in the treatment of cocaine withdrawal and craving. Nevertheless, the selection of an inpatient hospital regime hampered the demonstration of the superiority of caffeine treatment versus placebo.