Energy Drinks & Driving Ability

Utrecht Institute for Pharmaceutical Sciences

Status: Completed

Conditions: Driver Sleepiness

Treatments: Other: Red Bull Energy drink

Study type: Interventional

Funder types: Other

Identifiers

NCT01007877

09-037

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

No break

No Intervention group

Treatment:

Other: Red Bull Energy drink

Placebo Energy Drink

Placebo Comparator group

Description:

During a 15 minute break, subjects consume a placebo energy drink

Treatment:

Other: Red Bull Energy drink

Red Bull Energy Drink

Experimental group

Description:

during a 15 minute break, subjects consume Red Bull Energy Drink

Treatment:

Other: Red Bull Energy drink