Clinical trial NCT01007877: Energy Drinks & Driving Ability
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Driver Sleepiness
Keywords: sleepiness
driving
Lead sponsor: Utrecht Institute for Pharmaceutical Sciences
Sponsor class: OTHER
Collaborators: name: Red Bull GmbH
First posted: 2009-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane
timeFrame: the 2 hours of driving following the intervention
Secondary outcomes:
measure: Number of collisions
timeFrame: the 2 hours of driving following the intervention
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht University
Study officials:
affiliation: Utrecht University
name: Joris Verster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mets MA, Ketzer S, Blom C, van Gerven MH, van Willigenburg GM, Olivier B, Verster JC. Positive effects of Red Bull(R) Energy Drink on driving performance during prolonged driving. Psychopharmacology (Berl). 2011 Apr;214(3):737-45. doi: 10.1007/s00213-010-2078-2. Epub 2010 Nov 10.