Energy Drinks & Driving Ability

Driver Sleepiness Clinical Trial

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'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007877
• Other study ID #: 09-037
• Status: Completed
• Phase: N/A
• First received: October 13, 2009
• Last updated: April 8, 2011
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2011
• Source: Utrecht Institute for Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Driver Sleepiness

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Utrecht University	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Utrecht Institute for Pharmaceutical Sciences	Red Bull GmbH

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Mets MA, Ketzer S, Blom C, van Gerven MH, van Willigenburg GM, Olivier B, Verster JC. Positive effects of Red Bull® Energy Drink on driving performance during prolonged driving. Psychopharmacology (Berl). 2011 Apr;214(3):737-45. doi: 10.1007/s00213-010-20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane		the 2 hours of driving following the intervention	No
Secondary	Number of collisions		the 2 hours of driving following the intervention	No