失眠是一种非常普遍和昂贵的疾病,与增加的健康风险和医疗保健利用有关。有趣的是,消费者经常报告使用大麻以促进睡眠。然而,关于大麻对失眠症患者睡眠和白天功能的影响的客观研究有限。这项概念验证研究将评估单剂量的口服大麻药物对慢性失眠障碍参与者的睡眠和白天功能的影响。
随机,交叉,安慰剂对照,单剂量研究设计将用于测试含有10mgΔ9-四氢大麻酚(THC)和200mg大麻二酚(CBD)的口服油溶液(“ETC120”)在20名被诊断患有慢性失眠的参与者中的安全性和有效性。35-60岁的参与者将在2019年8月开始的18个月内招募。每位参与者将同时接受活性药物和匹配的安慰剂,以平衡的顺序,在两次隔夜研究评估访问中,每次访问之间至少有1周的洗脱期。主要结果是通过多导睡眠图评估的总睡眠时间和睡眠发作后的觉醒。此外,使用结构脑MRI的256通道高密度脑电图和来源建模将用于全面检查ETC120与安慰剂在睡眠和觉醒期间的大脑激活。第二天的认知功能,警觉性和模拟驾驶性能也将进行调查。
收到Bellberry人类研究伦理委员会的伦理批准(2018-04-284)。研究结果将在同行评审的开放获取期刊和学术会议上传播。
ANZCTRN12619000714189。
Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently reported by consumers to promote sleep. However, there is limited research on the effects of cannabis on sleep and daytime function in people with insomnia disorder using objective measures. This proof-of-concept
study will evaluate the effects of a single dose of an oral cannabis-based medicine on sleep and daytime function in participants with chronic insomnia disorder.
A randomised, crossover, placebo-controlled, single-dose
study design will be used to test the safety and efficacy of an oral oil solution (\'ETC120\') containing 10 mg Δ9-tetrahydrocannabinol (THC) and 200 mg cannabidiol (CBD) in 20 participants diagnosed with chronic insomnia disorder. Participants aged 35-60 years will be recruited over an 18-month period commencing August 2019. Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight
study assessment visits, with at least a 1-week washout period between each visit. The primary outcomes are total sleep time and wake after sleep onset assessed via polysomnography. In addition, 256-channel high-density electroencephalography and source modelling using structural brain MRI will be used to comprehensively examine brain activation during sleep and wake periods on ETC120 versus placebo. Next-day cognitive function, alertness and simulated driving performance will also be investigated.
Ethics approval was received from Bellberry Human Research Ethics Committee (2018-04-284). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.
ANZCTRN12619000714189.