Pilot Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol and the Ability to Drive in Chronic or Occasional Cannabis Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Ability to drive a motor vehicle measured using a driving simulator
研究概览
简要总结
Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.
详细描述
This study will examine:
- The relationship between THC blood levels and driving performance measured on a York Driving simulator
- The relationship between THC blood levels and reaction times as measured on the psychomotor vigilance test (PVT)
- the pharmacokinetics of THC in occasional and chronic cannabis consumers
- Determine the minimum blood concentration level of THC and 11-OH-THC, below which no effect of cannabis is observed
- Determine whether the polymorphism of CYP2C9 (* 3) is associated with the AUC, Cmax, and higher THC T1/2
- Determine if the polymorphism of CYP2C9 (* 3) is associated with different pharmacodynamic effects at a given THC level on performance measured by driving simulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sequence 1
- THC containing cigarettes 10mg
- THC containing cigarettes 30mg
- Placebo
干预措施: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo (Drug)
Sequence 2
- THC containing cigarettes 30mg
- Placebo
- THC containing cigarettes 10mg
干预措施: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo (Drug)
Sequence 3
- Placebo
- THC containing cigarettes 10mg
- THC containing cigarettes 30mg
干预措施: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo (Drug)
结局指标
主要结局
Ability to drive a motor vehicle measured using a driving simulator
时间窗: 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h
The association between THC blood concentrations and driving performances as measured by deviations from the centre of the road and variations of speed at 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h after smoking.
次要结局
- Psychomotor Vigilance Test (PVT) measures(0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h)
- THC pharmacokinetics of occasional and chronic users over 24 hours(24 hours)
- 24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3(24 hours)