The Effects of Cannabidiol on the Driving Ability of Healthy Adults

The Effects of Cannabidiol on the Driving Ability of Healthy Adults: a Clinical Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04590495

Enrollment

Registered

2020-10-19

Start date

2021-04-01

Completion date

2021-12-01

Last updated

2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Driving Performance, Mood, Sedation Complication

Brief summary

A randomized, parallel-group, double-blind, exploratory two-arm trial to assess the effects of CBD on driving ability along with changes in psychological status (i.e. mood, drowsiness, sedation) and cognitive function. Forty healthy West Virginia University (WVU) students will be allocated and randomized to receive: (1) 300 mg of pure CBD oil or (N=20) (2) placebo matched in appearance and taste (N=20). After consuming the study drug, each individual will participate in a 25-35-minute driving simulation and their driving performance measured. To assess changes in psychological status (i.e. mood, drowsiness, sedation) and drug impairment-related cognitive function, the Visual Analog Mood Scale, Stanford Sleepiness Scale , Digital Symbol Substitution Test, Trail Making Test Part A and B, Psychomotor Vigilance Test, and Simple Reaction Time test will also be administered to participants at baseline (prior to study drug consumption) and following completion of the driving simulation test. The entire protocol will be completed in one day and should take 4-4.5 hours to complete for each participant.

Interventions

DRUG300 mg Cannabidiol (CBD) oil

Participant will either be given a 300mg dosage of CBD oil. After consumption of the study drug, the participant will wait for 120 minutes to allow for digestion and for CBD to begin taking effect. Next, individuals will undergo a driving simulation and all participants will drive the same course. The simulator presents the individual with real life driving scenarios and is equipped with screens, a steering wheel, signals, and pedals. The participant will be instructed to drive the course for 25-35 minutes. They will be instructed to follow normal driving rules. The simulation will include highway, suburban, rural, and urban driving scenarios which will incorporate turns, changes in speed, and avoidance of cars/pedestrians.

DRUGPlacebo

Participant will either be given a placebo . After consumption of the study drug, the participant will wait for 120 minutes to allow for digestion and for CBD to begin taking effect. Next, individuals will undergo a driving simulation and all participants will drive the same course. The simulator presents the individual with real life driving scenarios and is equipped with screens, a steering wheel, signals, and pedals. The participant will be instructed to drive the course for 25-35 minutes. They will be instructed to follow normal driving rules. The simulation will include highway, suburban, rural, and urban driving scenarios which will incorporate turns, changes in speed, and avoidance of cars/pedestrians.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Intervention model description

A randomized, parallel-group, double-blind, exploratory two-arm trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

1\) the participant must be currently enrolled as a WVU student, 2) be 18-30 years of age at time of study, 3) have a current drivers' license issued from any state in the United States, 4) has driven at least once in the past 30 days 5) is able to speak and read English, 6) is willing to be randomized and comply with study requirements including a urine drug test on the day they consent to participate in the experiment and complete a test drive to ensure the absence of simulation sickness, 7) not currently taking any daily prescription medications other than birth control, 8) have not been diagnosed with any serious chronic disease by a licensed healthcare provider (including but not limited to Alzheimer's and related dementias, Parkinson's disease or other neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental illness, arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and fibromyalgia), and 9) has an individual able to drive them home after testing or is willing to be driven home by study staff after testing completion.

Exclusion criteria

Participants will be excluded if they 1) currently smoke or use tobacco products, 2) have used illegal drugs (including cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid, mushrooms, or marijuana) in the past 30 days, 3) has consumed CBD in the past 7 days, or 4) is currently pregnant or lactating

Design outcomes

Primary

Measure	Time frame	Description
Driving Performance - Percent of Time Spent Out of Lane	1.5 hour post intervention	From driving simulation. A greater percentage of time spent driving out of lane indicates worse performance. Min=0 max=100%
Driving Performance - Number of Collisions.	1.5 hour post intervention	From driving simulation. A greater number of collisions indicate worse performance. Min=0 max=infinity
Driving Performance - Brake Reaction Time	1.5 hour post intervention	Mean reaction time to stimuli from driving simulation. Longer reaction times indicate worst performance. Min=0 max=infinity
Driving Performance - Lateral Position in Lane	1.5 hour post intervention	Mean standard deviation of lateral position in lane under consistent speed from driving simulation. Larger standard deviations in lane position indicate worse performance. Min=0 max=infinity
Driving Performance-percent of Time Spent Driving Above Speed Limit	1.5 hour post intervention	From driving simulation. This is the percent of drive time that the driver spent driving above the speed limit. Greater percentage indicates worse performance.

Secondary

Measure	Time frame	Description
Change in Baseline DSST	4 hours after baseline	Digital Symbol Substitution Test (DSST). Number of correct symbols completed within 60 seconds. The test is scored by the degree of completion and accuracy over a timed 60 second period. More accurate completion (i.e. higher the score) indicates better cognitive functioning. Min=0 Max=90
Change in Baseline PVT	4 hours after baseline	Psychomotor Vigilance Test (PVT). Mean reaction time (in milliseconds) when responding to a stimuli that appears on a computer screen. Longer reaction time means worse vigilance. Min=0 max=infinity
Change in Baseline VAMS for Mental Sedation	4 hours after baseline	Visual Analog Mood Scale (VAMS). Mental sedation: sum of scores from questions 1, 4, 11, 13 on VAMS - higher scores indicate more mental sedation. Total min=0 Total max=400
Change in Baseline SRT--sound #2	4 hours after baseline	Simple Reaction Time test (SRT). Mean reaction time to stimuli that appears on a computer screen. Longer reaction times mean a decrease in reaction time. Min=0 max=infinity. Two separate sounds were emitted. Data were obtained for participants reaction to each separate sound
Change in Baseline SRT for Sound #1	4 hours after baseline	Simple Reaction Time test (SRT). Mean reaction time to stimuli that appears on a computer screen. Longer reaction times mean a decrease in reaction time. Min=0 max=infinity. Two separate sounds were emitted. Data were obtained for participants reaction to each separate sound
Change in Baseline VAMS--Physical Sedation	4 hours after baseline	Visual Analog Mood Scale (VAMS). Physical sedation: sum of scores from questions 3, 5, 6, 16 on VAMS - higher scores indicate more physical sedation. Total min=0 Total max=400
Change in Baseline SSS	4 hours after baseline	Stanford Sleepiness Scale (SSS). Self-reported sleepiness, The SSS is a Likert-type scale which assess mental and physical sedation and sleepiness, respectively, at that moment and time. SSS only consists of 1 question that is scaled from 1 to 7, with 7 being a higher or worse score (i.e. more sleepy and sedated)
Change in Baseline TMT Part A	4 hours after baseline	Trail Making Test (TMT). Time to accurately complete Part A . The TMT measures executive function and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment.
Change in Baseline TMT Part B	4 hours after baseline	Trail Making Test (TMT). Time to accurately complete Part B. The TMT measures executive function and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment.

Countries

United States

Participant flow

Recruitment details

The study took place at West Virginia University in Morgantown, West Virginia. Participants were recruited from April 1, 2021 until Dec 1, 2021 when the target enrollment was met.

Participants by arm

Arm	Count
300 mg Cannabidiol (CBD) Oil 300 mg Cannabidiol (CBD) oil: Participant will either be given a 300mg dosage of CBD oil. After consumption of the study drug, the participant will wait for 120 minutes to allow for digestion and for CBD to begin taking effect. Next, individuals will undergo a driving simulation and all participants will drive the same course. The simulator presents the individual with real life driving scenarios and is equipped with screens, a steering wheel, signals, and pedals. The participant will be instructed to drive the course for 25-35 minutes. They will be instructed to follow normal driving rules. The simulation will include highway, suburban, rural, and urban driving scenarios which will incorporate turns, changes in speed, and avoidance of cars/pedestrians.	21
Placebo Placebo: Participant will either be given a placebo . After consumption of the study drug, the participant will wait for 120 minutes to allow for digestion and for CBD to begin taking effect. Next, individuals will undergo a driving simulation and all participants will drive the same course. The simulator presents the individual with real life driving scenarios and is equipped with screens, a steering wheel, signals, and pedals. The participant will be instructed to drive the course for 25-35 minutes. They will be instructed to follow normal driving rules. The simulation will include highway, suburban, rural, and urban driving scenarios which will incorporate turns, changes in speed, and avoidance of cars/pedestrians.	19
Total	40

Baseline characteristics

Characteristic	Placebo	Total	300 mg Cannabidiol (CBD) Oil
Age, Continuous	21.0 years STANDARD_DEVIATION 2.7	21.2 years STANDARD_DEVIATION 2.7	21.4 years STANDARD_DEVIATION 2.8
Average daily caffeine consumption	10.1 ounces STANDARD_DEVIATION 9.8	11.5 ounces STANDARD_DEVIATION 11.5	12.9 ounces STANDARD_DEVIATION 13.1
Body mass index	25.6 Kilogram/meters squared STANDARD_DEVIATION 3.6	26.0 Kilogram/meters squared STANDARD_DEVIATION 5.2	26.3 Kilogram/meters squared STANDARD_DEVIATION 6.3
Employment status Employed	10 Participants	21 Participants	11 Participants
Employment status Not employed	9 Participants	19 Participants	10 Participants
Ever used cannabidiol previously Did not use Cannabidiol previously	14 Participants	31 Participants	17 Participants
Ever used cannabidiol previously Used Cannabidiol previously	5 Participants	9 Participants	4 Participants
Hours of sleep previous night	7.1 Hours STANDARD_DEVIATION 1.2	7.2 Hours STANDARD_DEVIATION 1.1	7.3 Hours STANDARD_DEVIATION 1
Miles driven per week	48.9 miles/week STANDARD_DEVIATION 43.7	49.5 miles/week STANDARD_DEVIATION 52.7	49.9 miles/week STANDARD_DEVIATION 60.5
Number of hours spent playing video games	8.6 Hours STANDARD_DEVIATION 13.8	7.1 Hours STANDARD_DEVIATION 10.2	5.6 Hours STANDARD_DEVIATION 5.1
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	6 Participants	3 Participants
Race (NIH/OMB) White	16 Participants	34 Participants	18 Participants
Sex: Female, Male Female	10 Participants	21 Participants	11 Participants
Sex: Female, Male Male	9 Participants	19 Participants	10 Participants
Undergraduate student status Graduate Student	4 Participants	12 Participants	8 Participants
Undergraduate student status Undergraduate Student	15 Participants	28 Participants	13 Participants
West Virginia Residency Non West Virginia Resident	6 Participants	15 Participants	9 Participants
West Virginia Residency West Virginia Resident	13 Participants	25 Participants	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 19
other Total, other adverse events	0 / 21	0 / 19
serious Total, serious adverse events	0 / 21	0 / 19

Outcome results

Primary

Driving Performance - Brake Reaction Time

Mean reaction time to stimuli from driving simulation. Longer reaction times indicate worst performance. Min=0 max=infinity

Time frame: 1.5 hour post intervention

Arm	Measure	Value (MEAN)	Dispersion
300 mg Cannabidiol (CBD) Oil	Driving Performance - Brake Reaction Time	0.60 Seconds	Standard Deviation 0.11
Placebo	Driving Performance - Brake Reaction Time	0.58 Seconds	Standard Deviation 0.12

p-value: 0.6068t-test, 2 sided

Primary

Driving Performance - Lateral Position in Lane

Mean standard deviation of lateral position in lane under consistent speed from driving simulation. Larger standard deviations in lane position indicate worse performance. Min=0 max=infinity

Time frame: 1.5 hour post intervention

Arm	Measure	Value (MEAN)	Dispersion
300 mg Cannabidiol (CBD) Oil	Driving Performance - Lateral Position in Lane	4.37 Feet	Standard Deviation 2.22
Placebo	Driving Performance - Lateral Position in Lane	3.88 Feet	Standard Deviation 2.49

p-value: 0.903Mann Whitney U Test

Primary

Driving Performance - Number of Collisions.

From driving simulation. A greater number of collisions indicate worse performance. Min=0 max=infinity

Time frame: 1.5 hour post intervention

Arm	Measure	Value (MEAN)	Dispersion
300 mg Cannabidiol (CBD) Oil	Driving Performance - Number of Collisions.	0.90 Number of collisions	Standard Deviation 1.09
Placebo	Driving Performance - Number of Collisions.	0.68 Number of collisions	Standard Deviation 0.95

p-value: 0.5699Mann Whitney U Test

Primary

Driving Performance-percent of Time Spent Driving Above Speed Limit

From driving simulation. This is the percent of drive time that the driver spent driving above the speed limit. Greater percentage indicates worse performance.

Time frame: 1.5 hour post intervention

Arm	Measure	Value (MEAN)	Dispersion
300 mg Cannabidiol (CBD) Oil	Driving Performance-percent of Time Spent Driving Above Speed Limit	5.83 Percent time driving over speed limit	Standard Deviation 6.02
Placebo	Driving Performance-percent of Time Spent Driving Above Speed Limit	8.27 Percent time driving over speed limit	Standard Deviation 9.58

p-value: 0.2668t-test, 2 sided

Primary

Driving Performance - Percent of Time Spent Out of Lane

From driving simulation. A greater percentage of time spent driving out of lane indicates worse performance. Min=0 max=100%

Time frame: 1.5 hour post intervention

Arm	Measure	Value (MEAN)	Dispersion
300 mg Cannabidiol (CBD) Oil	Driving Performance - Percent of Time Spent Out of Lane	4.41 Percent time spent driving out of lane	Standard Deviation 2.44
Placebo	Driving Performance - Percent of Time Spent Out of Lane	4.34 Percent time spent driving out of lane	Standard Deviation 2.09

p-value: 0.946Mann Whitney U Test

Secondary

Change in Baseline DSST

Digital Symbol Substitution Test (DSST). Number of correct symbols completed within 60 seconds. The test is scored by the degree of completion and accuracy over a timed 60 second period. More accurate completion (i.e. higher the score) indicates better cognitive functioning. Min=0 Max=90