Effect of Cannabidiol (CBD) on Vision and Driving

NCT ID: NCT06322303

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Cannabis Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo (CBD 0%)

Participants are required to vaporize a placebo at 0% CBD concentration

Group Type PLACEBO_COMPARATOR

Placebo (CBD 0%)

Intervention Type OTHER

Participants are required to vaporize placebo at 0% CBD concentration

CBD 15%

Participants are required to vaporize CBD at a concentration of 15%.

Group Type EXPERIMENTAL

CBD 15%

Intervention Type OTHER

Participants are required to vaporize CBD at a concentration of 15%.

CBD 30%

Participants are required to vaporize CBD at a concentration of 30%.

Group Type EXPERIMENTAL

CBD 30%

Intervention Type OTHER

Participants are required to vaporize CBD at a concentration of 30%.

Interventions

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Placebo (CBD 0%)

Participants are required to vaporize placebo at 0% CBD concentration

Intervention Type OTHER

CBD 15%

Participants are required to vaporize CBD at a concentration of 15%.

Intervention Type OTHER

CBD 30%

Participants are required to vaporize CBD at a concentration of 30%.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Sonia Ortiz Peregrina

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Granada

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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C-EXP-194-UGR23

Identifier Type: -

Identifier Source: org_study_id

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