Energy Drinks & Driving Ability

This study has been completed.
Sponsor:
Collaborator:
Red Bull GmbH
Information provided by:
Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT01007877
First received: October 13, 2009
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

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 Intervention
Driver Sleepiness
Other: Red Bull Energy drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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'

Further study details as provided by Utrecht Institute for Pharmaceutical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of collisions [ Time Frame: the 2 hours of driving following the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Joris C Verster, Utrecht University
ClinicalTrials.gov Identifier: NCT01007877     History of Changes
Other Study ID Numbers: 09-037
Study First Received: October 13, 2009
Last Updated: April 8, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
sleepiness
driving

ClinicalTrials.gov processed this record on July 10, 2014