Back to resultsThe Effects of Cannabidiol on the Driving Ability of Healthy Adults
Primary Purpose
Driving Performance, Cognitive Impairment, Sedation Complication
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
300 mg Cannabidiol (CBD) oil
Placebo
Sponsored by
About this trial
This is an interventional other trial for Driving Performance
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
Sites / Locations
- West Virginia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
300 mg Cannabidiol (CBD) oil
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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%
Driving Performance - Number of Collisions.
From driving simulation. A greater number of collisions indicate worse performance. Min=0 max=infinity
Driving Performance - Brake Reaction Time
Mean reaction time to stimuli from driving simulation. Longer reaction times indicate worst performance. Min=0 max=infinity
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
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.
Secondary Outcome Measures
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
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
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)
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.
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.
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
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
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
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
Full Information
NCT ID
NCT04590495
First Posted
October 9, 2020
Last Updated
August 21, 2022
Sponsor
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT04590495
Brief Title
The Effects of Cannabidiol on the Driving Ability of Healthy Adults
Official Title
The Effects of Cannabidiol on the Driving Ability of Healthy Adults: a Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Driving Performance, Cognitive Impairment, Sedation Complication, Mood
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, parallel-group, double-blind, exploratory two-arm trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
300 mg Cannabidiol (CBD) oil
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
300 mg Cannabidiol (CBD) oil
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Driving Performance - Percent of Time Spent Out of Lane
Description
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
Title
Driving Performance - Number of Collisions.
Description
From driving simulation. A greater number of collisions indicate worse performance. Min=0 max=infinity
Time Frame
1.5 hour post intervention
Title
Driving Performance - Brake Reaction Time
Description
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
Title
Driving Performance - Lateral Position in Lane
Description
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
Title
Driving Performance-percent of Time Spent Driving Above Speed Limit
Description
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
Secondary Outcome Measure Information:
Title
Change in Baseline VAMS for Mental Sedation
Description
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
Time Frame
4 hours after baseline
Title
Change in Baseline VAMS--Physical Sedation
Description
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
Time Frame
4 hours after baseline
Title
Change in Baseline SSS
Description
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)
Time Frame
4 hours after baseline
Title
Change in Baseline TMT Part A
Description
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.
Time Frame
4 hours after baseline
Title
Change in Baseline TMT Part B
Description
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.
Time Frame
4 hours after baseline
Title
Change in Baseline DSST
Description
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
Time Frame
4 hours after baseline
Title
Change in Baseline PVT
Description
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
Time Frame
4 hours after baseline
Title
Change in Baseline SRT for Sound #1
Description
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
Time Frame
4 hours after baseline
Title
Change in Baseline SRT--sound #2
Description
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
Time Frame
4 hours after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toni Marie Rudisill, MS, PhD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share these data.
Learn more about this trial
The Effects of Cannabidiol on the Driving Ability of Healthy Adults
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