ACTRN12620000941965已完成2 期
A randomised, double-blind, placebo-controlled crossover phase IIa pilot trial exploring the effect of purified oral cannabidiol (CBD) on exercise physiology and bioenergetics in healthy, endurance-trained individuals
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •a)greater than or equal to 18 and less than or equal to 45 years of age;
- •(b)Endurance-trained individuals; i.e. who have run an average of greater than or equal to 40 km·wk-1 for the last month (or more) and can sustain moderate intensity running exercise for >60-minutes;
- •(c)No reported use of cannabis or cannabinoids within the past 3 months; to be confirmed by a negative urine drug screen (UDS) at the medical screening; and
- •(d)Proficient in English (i.e. must not require an English translator).
排除标准
- •(a)Cannabis dependence or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision (ICD)-10 criteria or at a medical doctor’s discretion;
- •(b)A history (self-reported) of allergic reaction (e.g. rhinitis, urticaria, contact dermatitis, anaphylaxis) to cannabis, cannabis products or cannabinoids;
- •(c)A history (self-reported) of a clinically significant adverse response to cannabidiol (CBD);
- •(d)A history of a major psychiatric disorder within the previous 12 months, as per the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria or at the medical doctor’s discretion, except, mild to moderate depression (score <20 on the Beck Depression Inventory [BDI] or mild to moderate anxiety (score <16 on the Beck Anxiety Inventory [BAI];
- •(e) A history of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire (PHQ)-9;
- •(f)A (self-reported) history of, or current, cardiovascular, respiratory, renal, neurological, gastrointestinal, or endocrinological disorders;
- •(g)A major illness or injury that interrupted their usual training routine for a period of greater than or equal to 3 weeks during the past 3 months;
- •(h)Inability to refrain from consuming alcohol (24 h) and caffeine (12 h) prior to each experimental trial;
- •(i)Inability to refrain from using anti-inflammatory medications (24 h) prior to each experimental trial;
- •(j)Inability to refrain from using other central nervous system active drugs (e.g. cannabis, opioids, benzodiazepines) while participating in this project;
- •(k)Use of medications that may influence CBD metabolism (e.g. inducers or inhibitors of the CYP450 enzyme system);
- •(l)Use of medications handled by transporter proteins or CYP enzymes that are inhibited by CBD, such as anticoagulants, calcium channel blockers, beta blockers, sulfonylureas and anti-convulsants; and
- •(m)Required to complete mandatory drug testing for cannabis (e.g. workplace testing, anti-doping in sport testing).
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