Phase 2
N=40
The Effects of Cannabidiol on the Driving Ability of Healthy Adults
Driving Performance · Cognitive Impairment · Sedation Complication · Mood
Bottom Line
View on ClinicalTrials.gov: NCT04590495 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Driving Performance - Percent of Time Spent Out of Lane — 4.41; 4.34 Percent time spent driving out of lane — p=0.9460
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 300 mg Cannabidiol (CBD) oil (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- West Virginia University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Driving Performance - Percent of Time Spent Out of Lane |
4.41; 4.34 | 0.9460 |
| PRIMARY Driving Performance - Number of Collisions. |
0.90; 0.68 | 0.5699 |
| PRIMARY Driving Performance - Brake Reaction Time |
0.60; 0.58 | 0.6068 |
| PRIMARY Driving Performance - Lateral Position in Lane |
4.37; 3.88 | 0.9030 |
| PRIMARY Driving Performance-percent of Time Spent Driving Above Speed Limit |
5.83; 8.27 | 0.2668 |
| SECONDARY Change in Baseline VAMS for Mental Sedation |
148.7; 161.3 | 0.8749 |
| SECONDARY Change in Baseline VAMS--Physical Sedation |
135.6; 152.7 | 0.7922 |
| SECONDARY Change in Baseline SSS |
2.67; 2.63 | 0.9925 |
| SECONDARY Change in Baseline TMT Part A |
14.2; 15.6 | 0.2628 |
| SECONDARY Change in Baseline TMT Part B |
29.7; 37.1 | 0.0347 sig |
| SECONDARY Change in Baseline DSST |
74.5; 71.8 | 0.6331 |
| SECONDARY Change in Baseline PVT |
331.7; 330.0 | 0.4720 |
| SECONDARY Change in Baseline SRT for Sound #1 |
241.4; 244.6 | 0.0200 sig |
| SECONDARY Change in Baseline SRT--sound #2 |
239.6; 240.4 | 0.0620 |
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
- 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
Data sourced from ClinicalTrials.gov (NCT04590495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.