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NCT04590495 · ClinicalTrials.gov registry record · Phase 2
The Effects of Cannabidiol on the Driving Ability of Healthy Adults
A Phase 2 study of Cognitive Impairment and Mood, sponsored by West Virginia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04590495: Completed Phase 2 study of Cognitive Impairment and Mood, sponsored by West Virginia University.
NCT04590495 is a Phase 2 study of Cognitive Impairment and Mood that has completed, run by West Virginia University. The registered enrollment target is 40 participants, below the 665-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04590495, a Phase 2 study of Cognitive Impairment and Mood, has completed, sponsored by West Virginia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
From driving simulation. A greater percentage of time spent driving out of lane indicates worse performance. Min=0 max=100%
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 300 mg Cannabidiol (CBD) oil
Study Locations (1)
West Virginia
- West Virginia University - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2021-12-01 |
| Phase | Phase 2 |
What the finished NCT04590495 record still lists
NCT04590495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 665-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (94% lower).
The record links to 4 conditions, with Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04590495 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT04590495 about?
NCT04590495 is a clinical study titled "The Effects of Cannabidiol on the Driving Ability of Healthy Adults". 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 rando...
What is the current status of trial NCT04590495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2021-04-01. Estimated completion is 2021-12-01.
What conditions does trial NCT04590495 study?
This clinical trial studies the following conditions: Cognitive Impairment, Mood, Sedation Complication, Driving Performance.
What interventions are being tested in trial NCT04590495?
The interventions under investigation include: Placebo (DRUG), 300 mg Cannabidiol (CBD) oil (DRUG).
Who is sponsoring clinical trial NCT04590495?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04590495 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04590495's enrollment target sits among peer trials
40 78th of 105 higher than 23 of 105 other Cognitive Impairment trials
participants (enrollment target), bucketed by value
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