The Effects of Cannabidiol on the Driving Ability of Healthy Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Driving Performance, Cognitive Impairment, Sedation Complication, Mood

Intervention / Treatment
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* Drug: 300 mg Cannabidiol (CBD) oil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, parallel-group, double-blind, exploratory two-arm trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 300 mg Cannabidiol (CBD) oil<br> | Drug: 300 mg Cannabidiol (CBD) oil<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | 1.5 hour post intervention | 
| Driving Performance - Number of Collisions. | From driving simulation. A greater number of collisions indicate worse performance. Min=0 max=infinity | 1.5 hour post intervention | 
| Driving Performance - Brake Reaction Time | Mean reaction time to stimuli from driving simulation. Longer reaction times indicate worst performance. Min=0 max=infinity | 1.5 hour post intervention | 
| 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 | 1.5 hour post intervention | 
| 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. | 1.5 hour post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline VAMS for Mental Sedation | 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 | 4 hours after baseline | 
| Change in Baseline VAMS--Physical Sedation | 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 | 4 hours after baseline | 
| Change in Baseline SSS | 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) | 4 hours after baseline | 
| Change in Baseline TMT Part A | 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. | 4 hours after baseline | 
| Change in Baseline TMT Part B | 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. | 4 hours after baseline | 
| 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 | 4 hours after baseline | 
| Change in Baseline PVT | 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 | 4 hours after baseline | 
| Change in Baseline SRT for Sound #1 | 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 | 4 hours after baseline | 
| Change in Baseline SRT--sound #2 | 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 | 4 hours after baseline |