Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in eye gaze
研究概览
简要总结
Cannabis is one of the widely used psychoactive substances in the world. With increasing legalization, the prevalence of driving under the influence of cannabis will undoubtedly rise. At present, roadside detection of cannabis intoxication is largely dependent on drug recognition experts who rely on changes in eye movements when impaired. In this regard, use of eye trackers can help to detect impairment in drivers. The purpose of the present study is to determine the feasibility of the use of eye trackers in detecting impairment in participants who smoked a cannabis cigarette.
详细描述
Participants will attend one study session after determination of eligibility. During this session, they will smoke a cannabis cigarette with 12.5% THC prior to driving a simulator. Driving will be assessed prior to smoking cannabis and at 7 time points after smoking cannabis. Eye tracking measures will also be taken while driving after smoking cannabis. Blood will be drawn for determination of levels of the psychoactive substance THC and its metabolites. Saliva tests, urine tests and subjective tests will also be performed at various times points after smoking cannabis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weekly use of cannabis (1 to 4 days per week) confirmed by urine point-of-care testing;
- •19-26 years of age;
- •holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
- •Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to the study session;
- •Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study;
- •Provides written and informed consent.
排除标准
- •Urine toxicology screens negative for cannabis upon eligibility assessment;
- •Diagnosis of severe medical or psychiatric conditions;
- •Females: Pregnancy or breastfeeding;
- •Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);
- •Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants);
- •First-degree relative diagnosed with schizophrenia.
研究组 & 干预措施
Cannabis sativa
a 750 mg cannabis cigarette with 12.5% THC
干预措施: Cannabis Sativa (Drug)
结局指标
主要结局
Change in eye gaze
时间窗: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Measures of eye movement with an eye tracker
次要结局
- Change in saccades(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in blinking speed(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in pupil size(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in eye fixations(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in blinking rate(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in blinking duration(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in mean speed on the driving simulator(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in minimum time to collision on the driving simulator(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in number of collisions(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in standard deviation of speed on the driving simulator(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in heart rate(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in temperature(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in number of respirations per minute(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in maximum speed on the driving simulator(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in standard deviation of lateral position on the driving simulator(baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in saliva THC detection(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in diastolic blood pressure(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in blood concentrations of delta-9-tetrahydrocannabinol(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in systolic blood pressure(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in blood concentrations of carboxy-tetrahydrocannabinol(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)
- Change in Subjective cannabis effects with a visual analog scale(baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours)