Clinical trial NCT04590495: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Driving Performance
Cognitive Impairment
Sedation Complication
Mood
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, parallel-group, double-blind, exploratory two-arm trial.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Driving Performance - Percent of Time Spent Out of Lane
timeFrame: 1.5 hour post intervention
measure: Driving Performance - Number of Collisions.
timeFrame: 1.5 hour post intervention
measure: Driving Performance - Brake Reaction Time
timeFrame: 1.5 hour post intervention
measure: Driving Performance - Lateral Position in Lane
timeFrame: 1.5 hour post intervention
measure: Driving Performance-percent of Time Spent Driving Above Speed Limit
timeFrame: 1.5 hour post intervention
Secondary outcomes:
measure: Change in Baseline VAMS for Mental Sedation
timeFrame: 4 hours after baseline
measure: Change in Baseline VAMS--Physical Sedation
timeFrame: 4 hours after baseline
measure: Change in Baseline SSS
timeFrame: 4 hours after baseline
measure: Change in Baseline TMT Part A
timeFrame: 4 hours after baseline
measure: Change in Baseline TMT Part B
timeFrame: 4 hours after baseline
measure: Change in Baseline DSST
timeFrame: 4 hours after baseline
measure: Change in Baseline PVT
timeFrame: 4 hours after baseline
measure: Change in Baseline SRT for Sound #1
timeFrame: 4 hours after baseline
measure: Change in Baseline SRT--sound #2
timeFrame: 4 hours after baseline
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Toni Marie Rudisill, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: