NCT02771587

Interaction of Alcohol With Energy Drinks

Effects of Alcohol and Energy Drinks on Driving Performance and Bleeding Risk

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Alcohol-Related Disorders
• Drinking and Driving

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Alcohol and energy drink	Multiple oral dose of alcohol Multiple oral dose of energy drink
DIETARY_SUPPLEMENT	Alcohol	Multiple oral dose of alcohol
DIETARY_SUPPLEMENT	Energy drink	Multiple oral dose of energy drink
DIETARY_SUPPLEMENT	Placebo	Multiple oral dose of water Multiple oral dose of non-caffeinated soft drink

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-05-13
• Last updated: 2016-10-19

Locations

2 sites across 1 country: Spain