ACTRN12622000717752招募中2 期
The Acute Effects of Cannabidiol on Affective and Physiological Responses to Exercise in Healthy Endurance-Trained Runners: A Randomised, Double-blind, Placebo-controlled, Dose-ranging, Crossover Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •(a)Healthy individuals aged between 18–45 years
- •(b)Endurance-trained runners, i.e., who have run an average of more 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) The use of hormonal contraception for more than (or equal to) 3 months (for females)
- •(d)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
- •(e)Proficient in English and able to provide informed consent
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)Pregnant or lactating. All female volunteers of child-bearing potential will be required to complete a human chorionic gonadotrophin (hCG) urine screen to rule out pregnancy at the medical screening and prior to each treatment session. All females of child-bearing potential and males with female partners must agree to use a reliable form of contraception during and one month following their participation in this project
- •(h)A major illness or injury that interrupted their usual training routine for a period of more than (or equal to) 3 weeks during the past 3 months;
- •(i)Inability to refrain from using anti-inflammatory medications (4 days) prior to each treatment session;
- •(j)Inability to refrain from consuming alcohol (24 h) and caffeine (12 h) prior to each treatment session;
- •(k)Inability to refrain from using cannabis, cannabinoids and illicit drugs while participating in this project;
- •(l) Use of medications that may influence CBD metabolism (e.g. inducers or inhibitors of the CYP450 enzyme system);
- •(m)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
- •(n)Required to complete mandatory drug testing for cannabis (e.g., workplace testing)
- •(o) Competing in a World Anti-Doping Agency (WADA) sanctioned sporting event (within 3 months).
研究者
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