Alcohol-Related Disorders Clinical Trial
Official title:
Effects of Alcohol and Energy Drinks on Driving Performance and Bleeding Risk
The main objective of the project is to assess whether there is an interaction between the
effects of ethanol and energy drinks on driving performance.
Secondary objectives include: to evaluate subjective effects (drunkenness) after
administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine
and taurine after alcohol and energy drinks administration and to assess if there is an
increased risk of bleeding when both drinks are taken together.
Consumption of energy drinks improve psychomotor performance and alertness. These drinks contain mostly caffeine, taurine and vitamins. Its consumption associated with ethanol may reduce feelings of drunkenness as the stimulant effects of caffeine could counteract the depressing effects of ethanol on the central nervous system. Reducing the perception of intoxication may predispose the intoxicated person to engage in risky behaviors such as driving under the influence of ethanol and therefore can increase the risk of a traffic accident. Furthermore, the combination of both beverages may increase the risk of bleeding in case of injury as anticoagulant effects have been described for ethanol while antiplatelet effects have been described for caffeine and taurine. A randomized clinical trial will be performed in healthy volunteers administering 4 treatment conditions: alcohol+energy drink, alcohol+placebo of energy drink, placebo of alcohol+energy drink and placebo of alcohol+placebo of energy drink. A multiple dose will be administered separated by 1 hour. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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