NCT06322303

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

February 29, 2024

Last Update Submit

March 20, 2024

Conditions

Cannabis Use

Keywords

cannabiscannabidiolvisiondriving performance

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    Participants are assessed 20 minutes after vaporization

  • Change in contrast sensitivity after cannabidiol vaporization

    Contrast thresholds are obtained for different spatial frequencies

    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.

    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.

    Participants are assessed 20 minutes after vaporization

Secondary Outcomes (4)

  • Driving simulator: standard deviation of the lateral lane position (SDLP)

    Participants are assessed 20 minutes after vaporization

  • Distance travelled outside the lane

    Participants are assessed 20 minutes after vaporization

  • Mean speed

    Participants are assessed 20 minutes after vaporization

  • Angular velocity of the steering wheel

    Participants are assessed 20 minutes after vaporization

Study Arms (3)

Placebo (CBD 0%)

PLACEBO COMPARATOR

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

Other: Placebo (CBD 0%)

CBD 15%

EXPERIMENTAL

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

Other: CBD 15%

CBD 30%

EXPERIMENTAL

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

Other: CBD 30%

Interventions

Placebo (CBD 0%)OTHER

Participants are required to vaporize placebo at 0% CBD concentration

Placebo (CBD 0%)
CBD 15%OTHER

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

CBD 15%
CBD 30%OTHER

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

CBD 30%

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 21, 2024

Study Start

February 1, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2025

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations

ES(1)