Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
研究概览
简要总结
This primary aim of this study is to assess the effects of passive (second-hand) inhalation of cannabis smoke on toxicological analysis of "native" oral fluid (saliva), urine and blood specimens. The results of this study will help inform the validity of oral fluid as a biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation of cannabis smoke could result in a positive toxicology result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Participants are blind to the THC concentrations of cannabis being administered
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 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
Cannabis 5% THC, No Ventilation
Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 5% THC and in a room with no ventilation.
干预措施: Cannabis (Drug)
Cannabis 11% THC, No Ventilation
Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC and in a room with no ventilation.
干预措施: Cannabis (Drug)
Cannabis 11% THC, Ventilation
Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation.
干预措施: Cannabis (Drug)
结局指标
主要结局
Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
时间窗: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure
After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.
次要结局
- Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid(Samples collected 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure)
- Subjective VAS Drug Effect(immediately post cannabis exposure.)