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临床试验/ACTRN12616000414415
ACTRN12616000414415已完成未知

The effects of medicinal cannabinoids on driving in healthy adults with prior cannabis experience

The University of Sydney0 个研究点目标入组 14 人开始时间: 2016年3月31日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
14

研究概览

简要总结

Both active cannabis types increased lane weaving during a car-following task but had little effect on other driving performance measures. Active cannabis types impaired performance on the Digit Symbol Substitution Task (DSST), Divided Attention Task (DAT) and Paced Auditory Serial Addition Task (PASAT) with impairment on the latter two tasks worse with THC/CBD equivalent cannabis. Subjective drug effects (e.g., “stoned”) and confidence in driving ability did not vary with CBD content. Peak plasma THC concentrations were higher following THC/CBD equivalent cannabis relative to THC-dominant cannabis, suggesting a possible pharmacokinetic interaction.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
All

入选标准

  • (a)At least 18 years of age, and no more than 50 years of age
  • (b)Prior experience with cannabis (>10 lifetime exposures, <2x/week in previous 2 months)
  • (c)In possession of full Australian drivers license for at least 1 year
  • (d)Proficiency in English, and willing and capable of providing informed consent to the study procedures

排除标准

  • (a)Any clinically significant prior adverse response to cannabis, cannabinoid products or synthetic cannabinoids, as assessed by an Addiction Medicine specialist (e.g. panic or other anxiety attacks, arrhythmia, falls, seizures)
  • (b)Cannabis dependence (ICD-10 criteria)
  • (c)A desire to abstain from cannabis use
  • (d)Past year mood or anxiety disorder (DSM-V criteria)
  • (e)Lifetime manic episode or psychotic illness (DSM-V criteria), or suspected family history of schizophrenia
  • (f)Interest in treatment for cannabis use
  • (g)Hypertension, cardiovascular disease, chronic pulmonary disease or asthma
  • (h)Under 18 years of age or over 50 years of age
  • (i)Use of medications that may impact upon the metabolism and excretion of cannabinoids (e.g. CYP450 enyzme inducers/inhibitors), or may impact upon driving ability (e.g. mood stabilisers, sedatives); and
  • (j)Pregnancy (primary plasma hCG screen in women of child bearing potential, confirmed with blood test if urine test positive) and women of child bearing potential must agree to using a reliable form of contraception during and one month after completion of the project.
  • (k)Required to complete drug testing for cannabis (e.g. workplace testing; court order)

研究者

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