Clinical Trial: Interaction of Alcohol With Energy Drinks

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Alcohol and Energy Drinks on Driving Performance and Bleeding Risk

Brief 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 Summary: 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.
Sponsor: Parc de Salut Mar

Current Primary Outcome: Change in tracking test performance [ Time Frame: From baseline till 4 hours after administration ]

The total time outside the road will be measured in the tracking test


Original Primary Outcome: Change in simple reaction time (SRT) [ Time Frame: From baseline till 4 hours after administration ]

Test will be performed using the computerized cognitive testing battery CANTAB and mean latency will be measured


Current Secondary Outcome:

  • Change in simple reaction time (SRT) [ Time Frame: From baseline till 4 hours after administration ]
    Test will be performed using the computerized cognitive testing battery CANTAB and mean latency will be measured
  • Change in movement estimation [ Time Frame: From baseline till 4 hours after administration ]
    The lapse of time between actual and predicted time will be measured in a movement estimation task
  • Change in memory function [ Time Frame: From baseline till 4 hours after administration ]
    The N-Back test will be performed with 2 different options: 0 back test and 2 back test
  • Change in drunkenness [ Time Frame: From baseline till 8 hours after administration ]
    Drunkenness will be measured using a visual analog scale (0-100 mm)
  • Change in drowsiness [ Time Frame: From baseline till 8 hours after administration ]
    Drowsiness will be measured using a visual analog scale (0-100 mm)
  • Change in headache [ Time Frame: From baseline till 8 hours after administration ]
    Headache will be measured using a visual analog scale (0-100 mm)
  • Change in palpitations [ Time Frame: From baseline till 8 hours after administration ]
    Palpitations will be measured using a visual analog scale (0-100 mm)
  • Change in anxiety [ Time Frame: From baseline till 8 hours after administration ]
    Anxiety will be measured using a visual analog scale (0-100 mm)
  • Change in subjective effects measured with Addiction Research Center Inventory (ARCI) [ Time Frame: From baseline till 8 hours after administration ]
    Subjective effects of alcohol and caffeine will be measured using Addiction Research Center Inventory
  • Change in subjective effects measured with Biphasic alcohol effects scale (BAES) [ Time Frame: From baseline till 8 hours after administration ]
    Subjective effects of alcohol will be measured using BAES
  • Change in blood pressure [ Time Frame: From baseline till 8 hours after administration ]
    Systolic and diastolic blood pressure will be measured
  • Change in heart rate [ Time Frame: From baseline till 8 hours after administration ]
    Heart rate will be measured
  • Change in oral temperature [ Time Frame: From baseline till 8 hours after administration ]
    Oral temperature will be measured
  • Number of participants with serious and non-serious adverse events [ Time Frame: From inclusion till one week after the last experimental session ]
    Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators
  • Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations [ Time Frame: From baseline till 8 hours after administration ]
    Calculation of AUC of ethanol concentrations obtained baseline and 0.25, 0.50h , 0.75, 1, 1.50, 1.75, 2, 2.25, 2.5, 3, 4, 6 and 8h after administration
  • Area under the concentration-time curve (AUC 0-8h) of taurine blood concentrations [ Time Frame: From baseline till 8 hours after administration ]
    Calculation of AUC of ethanol concentrations obtained baseline and 0.50,1, 1.50, 2, 4, 6 and 8h after administration
  • Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations [ Time Frame: From baseline till 8 hours after administration ]
    Calculation of AUC of ethanol concentrations obtained baseline and 0,25, 0.50,1, 1.50, 2, 3, 4, 6 and 8h after administration
  • Area under the concentration-time curve (AUC 0-8h) of ethanol breath air concentrations [ Time Frame: From baseline till 8 hours after administration ]
    Calculation of AUC of ethanol concentrations obtained baseline and 0.25, 0.50, 0.75,1, 1.50, 1.75, 2, 2.25, 2.5, 3, 4, 6 and 8h after administration
  • Maximum concentration (Cmax) of taurine [ Time Frame: From baseline till 8 hours after administration ]
  • Maximum concentration (Cmax) of ethanol [ Time Frame: From baseline till 8 hours after administration ]
  • Maximum concentration (Cmax) of caffeine [ Time Frame: From baseline till 8 hours after administration ]
  • Time

    Original Secondary Outcome:

    • Change in tracking test performance [ Time Frame: From baseline till 4 hours after administration ]
      The total time outside the road will be measured in the tracking test
    • Change in movement estimation [ Time Frame: From baseline till 4 hours after administration ]
      The lapse of time between actual and predicted time will be measured in a movement estimation task
    • Change in memory function [ Time Frame: From baseline till 4 hours after administration ]
      The N-Back test will be performed with 2 different options: 0 back test and 2 back test
    • Change in drunkenness [ Time Frame: From baseline till 8 hours after administration ]
      Drunkenness will be measured using a visual analog scale (0-100 mm)
    • Change in drowsiness [ Time Frame: From baseline till 8 hours after administration ]
      Drowsiness will be measured using a visual analog scale (0-100 mm)
    • Change in headache [ Time Frame: From baseline till 8 hours after administration ]
      Headache will be measured using a visual analog scale (0-100 mm)
    • Change in palpitations [ Time Frame: From baseline till 8 hours after administration ]
      Palpitations will be measured using a visual analog scale (0-100 mm)
    • Change in anxiety [ Time Frame: From baseline till 8 hours after administration ]
      Anxiety will be measured using a visual analog scale (0-100 mm)
    • Change in subjective effects measured with Addiction Research Center Inventory (ARCI) [ Time Frame: From baseline till 8 hours after administration ]
      Subjective effects of alcohol and caffeine will be measured using Addiction Research Center Inventory
    • Change in subjective effects measured with Biphasic alcohol effects scale (BAES) [ Time Frame: From baseline till 8 hours after administration ]
      Subjective effects of alcohol will be measured using BAES
    • Change in blood pressure [ Time Frame: From baseline till 8 hours after administration ]
      Systolic and diastolic blood pressure will be measured
    • Change in heart rate [ Time Frame: From baseline till 8 hours after administration ]
      Heart rate will be measured
    • Change in oral temperature [ Time Frame: From baseline till 8 hours after administration ]
      Oral temperature will be measured
    • Number of participants with serious and non-serious adverse events [ Time Frame: From inclusion till one week after the last experimental session ]
      Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators
    • Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations [ Time Frame: From baseline till 8 hours after administration ]
      Calculation of AUC of ethanol concentrations obtained baseline and 0.25, 0.50h , 0.75, 1, 1.50, 1.75, 2, 2.25, 2.5, 3, 4, 6 and 8h after administration
    • Area under the concentration-time curve (AUC 0-8h) of taurine blood concentrations [ Time Frame: From baseline till 8 hours after administration ]
      Calculation of AUC of ethanol concentrations obtained baseline and 0.50,1, 1.50, 2, 4, 6 and 8h after administration
    • Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations [ Time Frame: From baseline till 8 hours after administration ]
      Calculation of AUC of ethanol concentrations obtained baseline and 0,25, 0.50,1, 1.50, 2, 3, 4, 6 and 8h after administration
    • Area under the concentration-time curve (AUC 0-8h) of ethanol breath air concentrations [ Time Frame: From baseline till 8 hours after administration ]
      Calculation of AUC of ethanol concentrations obtained baseline and 0.25, 0.50, 0.75,1, 1.50, 1.75, 2, 2.25, 2.5, 3, 4, 6 and 8h after administration
    • Maximum concentration (Cmax) of taurine [ Time Frame: From baseline till 8 hours after administration ]
    • Maximum concentration (Cmax) of ethanol [ Time Frame: From baseline till 8 hours after administration ]
    • Maximum concentration (Cmax) of caffeine [ Time Frame: From baseline till 8 hours after administration ]
    • Time to reach maximum concentration (tmax) of eth

      Information By: Parc de Salut Mar

      Dates:
      Date Received: May 10, 2016
      Date Started: June 2016
      Date Completion:
      Last Updated: October 18, 2016
      Last Verified: October 2016