The Effects of Cannabidiol on the Driving Ability of Healthy Adults

• ClinicalTrials.gov Identifier: NCT04590495
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Results First Posted: September 15, 2022
• Last Update Posted: September 15, 2022
• Sponsor: West Virginia University
• Information provided by (Responsible Party): Toni Marie Rudisill, West Virginia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Driving Performance; Cognitive Impairment; Sedation Complication; Mood	Drug: 300 mg Cannabidiol (CBD) oil; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized, parallel-group, double-blind, exploratory two-arm trial.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: The Effects of Cannabidiol on the Driving Ability of Healthy Adults: a Clinical Trial
• Actual Study Start Date: April 1, 2021
• Actual Primary Completion Date: December 1, 2021
• Actual Study Completion Date: December 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 300 mg Cannabidiol (CBD) oil	Drug: 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.
Placebo Comparator: Placebo	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Driving Performance - Percent of Time Spent Out of Lane [ Time Frame: 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%
2. Driving Performance - Number of Collisions. [ Time Frame: 1.5 hour post intervention ]
   From driving simulation. A greater number of collisions indicate worse performance. Min=0 max=infinity
3. Driving Performance - Brake Reaction Time [ Time Frame: 1.5 hour post intervention ]
   Mean reaction time to stimuli from driving simulation. Longer reaction times indicate worst performance. Min=0 max=infinity
4. Driving Performance - Lateral Position in Lane [ Time Frame: 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
5. Driving Performance-percent of Time Spent Driving Above Speed Limit [ Time Frame: 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 Outcome Measures :

1. Change in Baseline VAMS for Mental Sedation [ Time Frame: 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
2. Change in Baseline VAMS--Physical Sedation [ Time Frame: 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
3. Change in Baseline SSS [ Time Frame: 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)
4. Change in Baseline TMT Part A [ Time Frame: 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.
5. Change in Baseline TMT Part B [ Time Frame: 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.
6. Change in Baseline DSST [ Time Frame: 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
7. Change in Baseline PVT [ Time Frame: 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
8. Change in Baseline SRT for Sound #1 [ Time Frame: 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
9. Change in Baseline SRT--sound #2 [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, West Virginia

West Virginia University

Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

West Virginia University

Investigators

• Principal Investigator: Toni Marie Rudisill, MS, PhD; West Virginia University

  Study Documents (Full-Text)

Documents provided by Toni Marie Rudisill, West Virginia University:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] September 27, 2021

More Information

• Responsible Party: Toni Marie Rudisill, Research Assistant Professor, West Virginia University
• ClinicalTrials.gov Identifier: NCT04590495
• Other Study ID Numbers: 2007073792
• First Posted: October 19, 2020
• Results First Posted: September 15, 2022
• Last Update Posted: September 15, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: We do not plan to share these data.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cannabidiol; Anticonvulsants