Cannabis UseEarly Phase 1NCT06322303
Effect of Cannabidiol (CBD) on Vision and Driving
A Early Phase 1 study testing CBD 15% and CBD 30% in people with Cannabis Use, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- CBD 15% and CBD 30%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Certain past or present medical conditions
- Current cannabis or alcohol use disorder
- Use of other drugs
- Pregnancy or lactation
- Simulator sickness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cannabidiol (CBD) Consumption on Visual Function and Driving Performance
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.
- Conditions
- Cannabis Use
- Being tested
- Placebo (CBD 0%), CBD 15%, CBD 30%
- Keywords
- cannabis, cannabidiol, vision, driving performance
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (CBD 0%)Other
Participants are required to vaporize placebo at 0% CBD concentration
CBD 15%Other
Participants are required to vaporize CBD at a concentration of 15%.
CBD 30%Other
Participants are required to vaporize CBD at a concentration of 30%.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (CBD 0%) | Placebo comparator | Participants are required to vaporize a placebo at 0% CBD concentration Receives: Other: Placebo (CBD 0%) |
| CBD 15% | Experimental | Participants are required to vaporize CBD at a concentration of 15%. Receives: Other: CBD 15% |
| CBD 30% | Experimental | Participants are required to vaporize CBD at a concentration of 30%. Receives: Other: CBD 30% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overall Driving Performance Score (ODPS) after cannabidiol 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.
Measured: Participants are assessed 20 minutes after vaporization
Change in motion detection sensitivity after cannabidiol 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.
Measured: Participants are assessed 20 minutes after vaporization
Change in contrast sensitivity after cannabidiol vaporization
Contrast thresholds are obtained for different spatial frequencies
Measured: Participants are assessed 20 minutes after vaporization
Change in visual acuity after cannabidiol vaporization
Visual acuity is assessed with a commercial test for distance vision.
Measured: Participants are assessed 20 minutes after vaporization
Change in fixations after cannabidiol vaporization
The number of fixations made on different stimuli of interest in a task environment is counted using an eye tracker system.
Measured: Participants are assessed 20 minutes after vaporization
Secondary outcomes (4)
Driving simulator: standard deviation of the lateral lane position (SDLP)
Measured: Participants are assessed 20 minutes after vaporization
Distance travelled outside the lane
The SDLP assesses the lane weaving that the subject performs in the lane and indicates whether the vehicle's position is consistent.
Measured: Participants are assessed 20 minutes after vaporization
Mean speed
Average speed is obtained and analyzed in relation to the speed limits for different sections.
Measured: Participants are assessed 20 minutes after vaporization
Angular velocity of the steering wheel
The angular velocity of the steering wheel is a metric that indicates the subject's ability to maintain the vehicle's position.
Measured: Participants are assessed 20 minutes after vaporization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Feb 2023
- Primary completion30 Sep 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Ortiz Peregrina, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322303
- Sponsor's protocol ID
- C-EXP-194-UGR23
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabidiol (CBD) Consumption on Visual Function and Driving Performance
- ClinicalTrials.gov ID
- NCT06322303
- Acronym / sponsor ID
- C-EXP-194-UGR23
- Conditions
- Cannabis Use
- Keywords
- cannabis, cannabidiol, vision, driving performance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (CBD 0%) | Placebo comparator | Other: Placebo (CBD 0%)Participants are required to vaporize a placebo at 0% CBD concentration |
| CBD 15% | Experimental | Other: CBD 15%Participants are required to vaporize CBD at a concentration of 15%. |
| CBD 30% | Experimental | Other: CBD 30%Participants are required to vaporize CBD at a concentration of 30%. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Certain past or present medical conditions
- Current cannabis or alcohol use disorder
- Use of other drugs
- Pregnancy or lactation
- Simulator sickness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (CBD 0%)Participants are required to vaporize placebo at 0% CBD concentration | Other | Placebo (CBD 0%) |
| CBD 15%Participants are required to vaporize CBD at a concentration of 15%. | Other | CBD 15% |
| CBD 30%Participants are required to vaporize CBD at a concentration of 30%. | Other | CBD 30% |
Primary outcome
Change in Overall Driving Performance Score (ODPS) after cannabidiol vaporization
Time frame: Participants 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 motion detection sensitivity after cannabidiol vaporization
Time frame: Participants 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 contrast sensitivity after cannabidiol vaporization
Time frame: Participants are assessed 20 minutes after vaporization
Contrast thresholds are obtained for different spatial frequencies
Change in visual acuity after cannabidiol vaporization
Time frame: Participants are assessed 20 minutes after vaporization
Visual acuity is assessed with a commercial test for distance vision.
Change in fixations after cannabidiol vaporization
Time frame: Participants 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.
4 secondary outcomes
Driving simulator: standard deviation of the lateral lane position (SDLP)
Time frame: Participants are assessed 20 minutes after vaporization
Distance travelled outside the lane
Time frame: Participants are assessed 20 minutes after vaporization
Mean speed
Time frame: Participants are assessed 20 minutes after vaporization
Angular velocity of the steering wheel
Time frame: Participants are assessed 20 minutes after vaporization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CBD 15% and CBD 30% in people with Cannabis Use, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overall Driving Performance Score (ODPS) after cannabidiol vaporization (time frame: Participants are assessed 20 minutes after vaporization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.