Effect of Cannabidiol (CBD) Consumption on Visual Function and Driving Performance
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in motion detection sensitivity after cannabidiol vaporization
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Placebo (CBD 0%)
Participants are required to vaporize a placebo at 0% CBD concentration
干预措施: Placebo (CBD 0%) (Other)
CBD 15%
Participants are required to vaporize CBD at a concentration of 15%.
干预措施: CBD 15% (Other)
CBD 30%
Participants are required to vaporize CBD at a concentration of 30%.
干预措施: CBD 30% (Other)
结局指标
主要结局
Change in motion detection sensitivity after cannabidiol vaporization
时间窗: 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 Overall Driving Performance Score (ODPS) after cannabidiol vaporization
时间窗: 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 contrast sensitivity after cannabidiol vaporization
时间窗: Participants are assessed 20 minutes after vaporization
Contrast thresholds are obtained for different spatial frequencies
Change in fixations after cannabidiol vaporization
时间窗: 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.
Change in visual acuity after cannabidiol vaporization
时间窗: Participants are assessed 20 minutes after vaporization
Visual acuity is assessed with a commercial test for distance vision.
次要结局
- Driving simulator: standard deviation of the lateral lane position (SDLP)(Participants are assessed 20 minutes after vaporization)
- Angular velocity of the steering wheel(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)
研究者
Sonia Ortiz Peregrina
Assistant Professor
Universidad de Granada