MedPath

Effect of Cannabidiol (CBD) on Vision and Driving

Early Phase 1
Active, not recruiting
Conditions
Cannabis Use
Interventions
Other: Placebo (CBD 0%)
Other: CBD 30%
Other: CBD 15%
Registration Number
NCT06322303
Lead Sponsor
Universidad de Granada
Brief Summary

The use of cannabis with ∆9-tetrahydrocannabinol (THC) content has been shown to have negative effects on vision and driving. The use of other cannabinoids, such as cannabidiol (CBD), which is not attributed with a psychoactive effect, is increasing significantly. This project aims to investigate whether consuming CBD can negatively affect visual function by assessing a wide range of visual parameters and whether these changes may pose a risk for everyday activities such as driving.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Being an occasional cannabis and/or cannabidiol user
  • Have a current driving licence
  • Have at least one year's driving experience
  • Drive at least once a week
  • Monocular visual acuity of at least 6/6 (Snellen) with habitual correction for driving
  • Absence of binocular disorders

Exclusion criteria:

  • Certain past or present medical conditions
  • Current cannabis or alcohol use disorder
  • Use of other drugs
  • Pregnancy or lactation
  • Simulator sickness.
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Placebo (CBD 0%)Placebo (CBD 0%)Participants are required to vaporize a placebo at 0% CBD concentration
CBD 30%CBD 30%Participants are required to vaporize CBD at a concentration of 30%.
CBD 15%CBD 15%Participants are required to vaporize CBD at a concentration of 15%.
Primary Outcome Measures
NameTimeMethod
Change in motion detection sensitivity after cannabidiol vaporizationParticipants are assessed 20 minutes after vaporization

The subject has to indicate the direction of movement of a pattern of moving dots. The percentage of correct answers is obtained for different degrees of coherence.

Change in Overall Driving Performance Score (ODPS) after cannabidiol vaporizationParticipants are assessed 20 minutes after vaporization

To obtain the ODPS, Z-scores were calculated from individual parameters such as the standard deviation of the lateral lane position or the distance travelled into the opposite lane. The z-score is defined as a measure of how many standard deviations an individual value is below or above the group mean. The average Z-score of the individual driving variables is called the ODPS.

Change in contrast sensitivity after cannabidiol vaporizationParticipants are assessed 20 minutes after vaporization

Contrast thresholds are obtained for different spatial frequencies

Change in fixations after cannabidiol vaporizationParticipants are assessed 20 minutes after vaporization

The number of fixations made on different stimuli of interest in a task environment is counted using an eye tracker system.

Change in visual acuity after cannabidiol vaporizationParticipants are assessed 20 minutes after vaporization

Visual acuity is assessed with a commercial test for distance vision.

Secondary Outcome Measures
NameTimeMethod
Driving simulator: standard deviation of the lateral lane position (SDLP)Participants are assessed 20 minutes after vaporization
Angular velocity of the steering wheelParticipants are assessed 20 minutes after vaporization

The angular velocity of the steering wheel is a metric that indicates the subject's ability to maintain the vehicle's position.

Distance travelled outside the laneParticipants are assessed 20 minutes after vaporization

The SDLP assesses the lane weaving that the subject performs in the lane and indicates whether the vehicle's position is consistent.

Mean speedParticipants are assessed 20 minutes after vaporization

Average speed is obtained and analyzed in relation to the speed limits for different sections.

Trial Locations

Locations (1)

University of Granada

🇪🇸

Granada, Spain

© Copyright 2025. All Rights Reserved by MedPath