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临床试验/EUCTR2018-003945-40-NL
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

Maastricht University0 个研究点目标入组 20 人开始时间: 2018年12月20日最近更新:
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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