EUCTR2018-003945-40-NL进行中(未招募)1 期
EFFECTS OF VAPORISED CANNABIS, WITH AND WITHOUT CBD, ON DRIVING AND COGNITION - VCAD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Occasional cannabis users (>10 lifetime exposures and <2x/week in the last 12 months)
- •Age between 20-50
- •Good physical health as determined by medical examination and laboratory analysis
- •Absence of any major medical, endocrine and neurological condition
- •Normal weight, body mass index (weight/height2) between 20 and 28 kg/m2
- •In possession of a valid driver license with at least 2 years driving experience (having driven > 3000 km/yr)
- •Written Informed Consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of drug abuse (other than the use of cannabis) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
- •Pregnancy or lactation (pregnancy test, if needed)
- •Hypertension (diastolic> 90; systolic> 140)
- •Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
- •Liver dysfunction
- •Use of medications that may impact upon driving ability (e.g. mood stabilisers, sedatives)
- •Any serious prior adverse response to cannabis
- •History of cardiac dysfunctions (e.g. arrhythmia, ischemic heart disease)
研究者
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