The Effects of Cannabidiol on the Driving Ability of Healthy Adults

NCT04590495 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2007073792
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Driving Performance; Cognitive Impairment; Sedation Complication; Mood

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Change in Baseline VAMS for Mental Sedation

  4 hours after baseline

• Change in Baseline VAMS--Physical Sedation

  4 hours after baseline

• Change in Baseline SSS

  4 hours after baseline

• Change in Baseline TMT Part A

  4 hours after baseline

• Change in Baseline TMT Part B

  4 hours after baseline

Study Arms (2)

300 mg Cannabidiol (CBD) oil

ACTIVE COMPARATOR

Drug: 300 mg Cannabidiol (CBD) oil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

300 mg Cannabidiol (CBD) oil DRUG

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.

300 mg Cannabidiol (CBD) oil

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cannabidiol; Oils

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Lipids

Limitations and Caveats

Only one dosage of CBD was utilized, and this dose may not reflect "normal" use of CBD. Participants were recruited from a university so results may not be generalizable to the general population. Previous studies have shown that CBD's max absorption occurs 2-5 hours post-consumption. To balance participant burden, a two-hour waiting period between dosing and simulation was chosen. It is possible that max absorption and full effect of the drug was not reached amongst some participants.

Results Point of Contact

• Title: Toni Marie Rudisill, MS, PhD
• Organization: West Virginia University

trudisill@hsc.wvu.edu

304-293-0687

Study Officials

• Toni Marie Rudisill, MS, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

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

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 15, 2022
• Results First Posted: September 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)