The Effects of Cannabidiol on the Driving Ability of Healthy Adults
Condition: Driving Performance; Cognitive Impairment; Sedation Complication; Mood
MeSH terms: Cognitive Dysfunction
Intervention: 300 mg Cannabidiol (CBD) oil; Placebo
Intervention description: 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.; 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.
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, parallel-group, double-blind, exploratory two-arm trial.
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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