A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis
试验速览
- 阶段
- 1 期
- 发起方
- UMC Utrecht
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Serum concentration over time
研究概览
简要总结
The purpose of this study is to investigate the processing of cannabis, and to investigate the occurrence of effects of cannabis on the cardiovascular system and the central nervous system; at higher levels of exposure.
详细描述
In Europe, cannabis is the most illicit used drug, mainly for its psychoactive properties (becoming "high" or "stoned"). The active compound in cannabis is THC (tetrahydrocannabinol). In recent years the strength of cannabis (marihuana) available on the market in the Netherland has increased (especially "netherweed"). The THC-content has increased from on average 8.6% in 2000 to on average 20.3% in 2004. Experienced users adapt their habit of smoking to the strength of the cannabis sigaret (joint). However, there is also a group of people, mainly young ones, who intent to smoke the joint entirely, and can therefore be exposed to higher levels of THC. Information is lacking about the effects of cannabis at higher levels of exposure. Because of this, the Ministry of Health, Welfare, and Sports of the Netherlands ordered the investigators to perform a study to gain more insight in this issue.
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
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Cannabis users (2-9 joints per month)
排除标准
- •Psychiatric illness
- •Evidence of excessive alcohol abuse
- •Use of other drugs
结局指标
主要结局
Serum concentration over time
Physical parameters (heart rate, blood pressure)
Psychomotor tests (such continuous attention)
Event related potentials
次要结局
- Self-reporting questionnaires