Health TrialsbyHealthPanel

The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex

ConditionsCannabidiol EffectsDriving Performance
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-30
SponsorWest Virginia University

About this trial

The objectives/purpose of this study are to comprehensively investigate the effects of non-prescription CBD on driving performance, drowsiness, sedation, and cognitive function in a large sample of healthy adults aged 18-30 years, with additional characterization of effects by dose and by sex, using a rigorous RCT design which will naturally mitigate confounding factors.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Possess a current drivers' license

Driven a motor vehicle at least once in the past 30 days

Able to read English

Test negative for all substances on a urine drug test and complete a test drive to ensure the absence of simulation sickness

Disqualifiers

Currently smoke, vape or use tobacco products, used CBD in the past 30 days

Used illegal drugs in the past 30 days (e.g., cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid diethylamide, psilocybin mushrooms, or marijuana)

Are pregnant or lactating at time of study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cannabidiol (CBD) Oil 300mg

    Drug

    Cannabidiol (CBD) Oil 300mg, 1 dose

  • Cannabidiol (CBD) Oil 150mg

    Drug

    Cannabidiol (CBD) Oil 150mg, 1 dose

  • Placebo Oil

    Drug

    Placebo Oil, 1 dose

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Cannabidiol (CBD) Oil 300mgActive comparator 1 intervention
Group B: Cannabidiol (CBD) Oil 150mgActive comparator 1 intervention
Group C: Placebo OilPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean standard deviation of lateral position

The driving simulator will measure mean standard deviation which is the amount a driver is weaving within the lane during the drive. Ranges from 0 to infinity, with higher means indicating worse performance.

Time frame
150 minutes post intervention
2

Number of collisions

The driving simulator will measure how many times a participant crashes into other vehicles, signs, pedestrians, etc. during the simulation. Ranges from 0 to infinity, with higher numbers indicating worse performance.

Time frame
150 minutes post intervention
3

Mean reaction time to stimuli

The driving simulator will measure the mean reaction time (seconds) that it takes for a person to brake when exposed to stimuli. Ranges from 0 to infinity, with higher means indicating worse performance.

Time frame
150 minutes post intervention
4

Percent of time driver is out of travel lane

The driving simulator will measure the percent of time that each driver spends driving outside their travel lane. Percent ranges from 0-100, with higher scores indicating worse performance.

Time frame
150 minutes post intervention

Secondary outcomes

1

Self-reported sleepiness scale

Sleepiness will be assessed via the Stanford Sleepiness Scale which is a one question Likert scale question that ask a person's sleepiness level at that moment in time. The scale ranges from 1-7 with higher scores indicating more sleepiness. This test will be administered on a laptop.

Time frame
baseline
2

Self-reported sleepiness scale

Sleepiness will be assessed via the Stanford Sleepiness Scale which is a one question Likert scale question that ask a person's sleepiness level at that moment in time. The scale ranges from 1-7 with higher scores indicating more sleepiness. This test will be administered on a laptop.

Time frame
200 minutes post intervention
3

Mental sedation score

The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 1,4,11, and 13 are summed together to get a mental sedation score. Higher scores indicate more sedation. This ranges from 0-400.This test will be administered on a laptop.

Time frame
baseline
4

Mental sedation score

The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 1,4,11, and 13 are summed together to get a mental sedation score. Higher scores indicate more sedation. This ranges from 0-400.This test will be administered on a laptop.

Time frame
200 minutes post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West Virginia University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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