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Energy Drinks & Driving Ability

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ClinicalTrials.gov Identifier: NCT01007877
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : April 11, 2011
Sponsor:
Collaborator:
Red Bull GmbH
Information provided by:
Utrecht Institute for Pharmaceutical Sciences

Brief Summary:

Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink counteracts driver sleepiness.

Objective: The objective of this study is to compare driving simulator performance after (1) a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3) continued driving.

Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy human volunteers, 21-35 years old.

Intervention: Each subject performs 3 test days:

  1. 4 hours continued driving
  2. 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving
  3. 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of the car.

Condition or disease Intervention/treatment Phase
Driver Sleepiness Other: Red Bull Energy drink Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 'Study to Investigate the Effects of an Energy Drink During a 15-minute Break Versus Continued Driving on Driving Performance in the STISIM Driving Simulator'
Study Start Date : September 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
No Intervention: No break Other: Red Bull Energy drink
During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.
Placebo Comparator: Placebo Energy Drink
During a 15 minute break, subjects consume a placebo energy drink
Other: Red Bull Energy drink
During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.
Experimental: Red Bull Energy Drink
during a 15 minute break, subjects consume Red Bull Energy Drink
Other: Red Bull Energy drink
During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.



Primary Outcome Measures :
  1. Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane [ Time Frame: the 2 hours of driving following the intervention ]

Secondary Outcome Measures :
  1. Number of collisions [ Time Frame: the 2 hours of driving following the intervention ]


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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • He/she is aged between 21 and 35 years old
  • BMI between 21 and 30,
  • 55-85 kg body weight
  • Non smoker
  • Written informed consent
  • Normal static binocular acuity, corrected or uncorrected
  • Normal hearing
  • Possession of a valid driver's license for at least 3 years
  • Regular driver (> 5000 km / year)
  • Be considered as reliable and mentally capable of adhering to the protocol.

Exclusion Criteria:

  • Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test
  • Use of psychoactive medication
  • Pregnancy
  • Positive alcohol breath test
  • Prior enrolment in the same study
  • Physical or mental illness
  • Excessive alcohol use (>21 alcoholic drinks per week)
  • Intake of caffeine-containing beverages under 2 or over 4 glasses per day
  • Regular consumption of Energy Drinks (>1 per month)
  • Shift worker (or no regular sleep pattern)
  • Epworth Sleepiness Score (ESS) > 10

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007877


Locations
Netherlands
Utrecht University
Utrecht, Netherlands, 3508TB
Sponsors and Collaborators
Utrecht Institute for Pharmaceutical Sciences
Red Bull GmbH
Investigators
Principal Investigator: Joris Verster, PhD Utrecht University

Publications of Results:
Responsible Party: Joris C Verster, Utrecht University
ClinicalTrials.gov Identifier: NCT01007877     History of Changes
Other Study ID Numbers: 09-037
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
sleepiness
driving