ACTRN12623000872639招募中2 期
A randomised, double-blind, placebo-controlled, parallel-group trial exploring the effect of purified oral cannabidiol (CBD) on psychosocial stress, situational anxiety, acute motion sickness and cybersickness experienced in a virtual reality environment in healthy individuals.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 74
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 50 Years（—）
- 性别
- All
入选标准
- •a) Healthy adults aged between 18-50 years.
- •b) Proficient in English (able to provide informed consent).
- •c) Residing in Greater Sydney NSW Australia.
- •d) Willing to follow the protocol requirements.
排除标准
- •a)Self-reported regular use (i.e., more than twice weekly) of any cannabis or cannabinoid-containing products including CBD in the past two weeks.
- •b)Self-reported regular use (i.e., more than twice weekly) use of psychotropic drugs (licit or illicit) (e.g., cannabis, amphetamines, cocaine, ecstasy (MDMA), LSD (acid), antidepressants, opioids, benzodiazepines) within the past two weeks.
- •c)Self-reported regular use (i.e., more than twice weekly) of medication that may affect the stress response (e.g., corticosteroids, beta-blockers) within the past two weeks
- •d)Self-reported history of allergic reactions (e.g., urticaria or anaphylaxis) to cannabis or cannabis-based products.
- •e)Self-reported history of liver disease, renal disease, epilepsy or heart disease (currently (i.e., within the past 2-weeks) controlled high blood pressure <140/90mmHg is acceptable)
- •f)Current (i.e., within the past 2-weeks) otologic (vestibular) disease
- •g)A history of repeated episodes of syncope
- •h)Pregnant, lactating, or trying to conceive.
- •i)Self-reported drug and/or alcohol dependence (or suspected drug and/or alcohol dependence as determined by the trial physician)
- •j)A medically diagnosed anxiety disorder (e.g., social anxiety disorder) within the past 12 months
- •k)Current suicide ideation (i.e., a score >0 on Question 9 of the Patient Health Questionnaire) or suspected suicide ideation as determined by the trial physician.
- •l)Current depression, anxiety, and stress scores outside the healthy range of the Depression Anxiety Stress Scale-21 (> moderate on DASS-21 for depression, anxiety and stress).
- •m)An uncontrolled chronic medical condition (mental or physical)
- •n)Self-reported high vulnerability to cybersickness or motion sickness.
- •o)Frequent (> weekly) use of VR technologies, which tends to produce desensitisation towards motion sickness.
- •p)Self-reported intense fear of heights.
研究者
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