ACTRN12619001552178已完成2 期
A randomised, double-blinded, crossover trial investigating the dose-dependent effects of purified oral cannabidiol (CBD) on simulated driving performance in healthy volunteers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
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 65 Years（—）
- 性别
- All
入选标准
- •(a)Between 18 and 65 years of age;
- •(b)No reported use of cannabis within the past 3 months; to be confirmed by a negative urine drug screen at the medical screening;
- •(c)In possession of full (unrestricted) Australian driver’s license for at least 1 y;
- •(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 criteria or at the medical officer’s discretion;
- •(b)Contraindications to cannabinoids, including clinically significant prior adverse response to cannabis, cannabinoid products or synthetic cannabinoids (e.g. panic, anxiety attacks, arrhythmia, falls, seizures or other);
- •(c)History of a major psychiatric disorder within the previous 12 months (except clinically managed mild depression) as per the Diagnostic and Statistical Manual of Mental Disorders-V criteria or at the medical officer’s discretion;
- •(d)History of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire-9;
- •(e)A diagnosed sleep disorder, as per the International Classification of Sleep Disorders Diagnostic and Coding manual or at the medical officer’s discretion;
- •(f)Pregnant or lactating. All female volunteers of childbearing potential will be required to complete a human chorionic gonadotrophin (hCG) urine screen to rule out pregnancy at the medical screening; females of childbearing potential and males with a female partner must agree to use a reliable form of contraception during and one month following their participation in this project;
- •(g)Inability to refrain from alcohol consumption 24 h prior to each experimental trial;
- •(h)Inability to refrain from using other central nervous system active drugs (e.g. opioids, benzodiazepines) while participating in this project;
- •(i)Use of medications that may influence CBD metabolism, such as inducers or inhibitors of the CYP450 enzyme system;
- •(j)Use of medications handled by transporter proteins or CYP enzymes that are inhibited by CBD, such as anticoagulants, calcium channel blockers, beta-blockers and sulfonylureas;
- •(k)Use of anticonvulsive medications, such as clobazam or valproate;
- •(l)Required to complete mandatory drug testing for cannabis (e.g. workplace testing; court order);
- •(m)A high habitual caffeine (i.e. >300 mg·d-1);
- •(n)At risk for developing driving simulator sickness, as determined at the medical screening using the Simulator Sickness Questionnaire;
- •(o)Body mass index (BMI) >30 kg·m2
研究者
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