Skip to main content
OpenTrials
Completed

NCT Number: NCT01007877

Energy Drinks & Driving Ability

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Driver Sleepiness Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleepiness

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Utrecht University

Utrecht, 3508TB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red Bull Energy drink

Other

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 outcomes

  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 outcomes

  1. Number of collisions

    Time frame: the 2 hours of driving following the intervention

Sponsors and collaborators

Lead sponsor

Utrecht Institute for Pharmaceutical Sciences

Other

Collaborators

  • Red Bull GmbH

Registry information

Official study 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'

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 4, 2009
Registry last updated
Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.