目的:失眠是最常见的睡眠障碍,很少有有效的药物治疗。轶事报道和最近的临床前研究表明,大麻酚(CBN),一种源自δ-9-四氢大麻酚的大麻成分,可能是一种有效的治疗方法。尽管如此,CBN对睡眠的孤立影响尚未在人类中进行系统研究。
方法:本协议文件描述了一个随机的,双盲,安慰剂对照,单剂量,三臂,cross-over,概念验证研究调查CBN对20名临床医生诊断为失眠障碍且失眠严重度指数评分≥15的参与者的睡眠和次日功能的影响。参与者接受30mgCBN的单一固定口服液体剂量,300毫克CBN和匹配的安慰剂,以随机顺序在三个治疗之夜;每个间隔2周的清洗期。参与者使用实验室多导睡眠图和第二天神经行为功能测试进行过夜睡眠评估。主要结果是睡眠开始几分钟后醒来。次要结果包括对传统睡眠分期的改变,非快速眼动(NREM)睡眠期间的睡眠发作延迟和绝对光谱功率。三级结果包括NREM睡眠期间睡眠纺锤波的变化,唤醒指数,REM睡眠期间的绝对频谱功率和主观睡眠质量。安全相关和探索性结果包括第二天模拟驾驶性能的变化,主观情绪和药物作用,姿势摇摆,警觉性和反应时间,过夜记忆巩固,睡前和睡后主观和客观嗜睡;和血浆,泌尿,和唾液大麻素浓度。这项研究将提供新的初步数据,CBN疗效和失眠障碍的安全性,这将为更大的临床试验提供信息。
背景:人类研究伦理委员会已获得Bellberry(2021-08-907)的批准。研究结果将在同行评审的期刊和学术会议上传播。
背景:NCT05344170。
Insomnia is the most prevalent sleep disorder, with few effective pharmacotherapies. Anecdotal reports and recent preclinical research suggest that cannabinol (CBN), a constituent of Cannabis sativa derived from delta-9-tetrahydrocannabinol, could be an effective treatment. Despite this, the isolated effects of CBN on sleep have yet to be systematically studied in humans.
The present protocol paper describes a randomised, double-blind, placebo-controlled, single-dose, three-arm, cross-over, proof-of-concept
study which investigates the effects of CBN on sleep and next-day function in 20 participants with clinician-diagnosed insomnia disorder and an Insomnia Severity Index Score ≥15. Participants receive a single fixed oral liquid dose of 30 mg CBN, 300 mg CBN and matched placebo, in random order on three treatment nights; each separated by a 2-week wash-out period. Participants undergo overnight sleep assessment using in-laboratory polysomnography and next-day neurobehavioural function tests. The primary outcome is wake after sleep onset minutes. Secondary outcomes include changes to traditional sleep staging, sleep-onset latency and absolute spectral power during non-rapid eye movement (NREM) sleep. Tertiary outcomes include changes to sleep spindles during NREM sleep, arousal indices, absolute spectral power during REM sleep and subjective sleep quality. Safety-related and exploratory outcomes include changes to next-day simulated driving performance, subjective mood and drug effects, postural sway, alertness and reaction time, overnight memory consolidation, pre and post-sleep subjective and objective sleepiness; and plasma, urinary, and salivary cannabinoid concentrations. The
study will provide novel preliminary data on CBN efficacy and safety in insomnia disorder, which will inform larger clinical trials.
Human Research Ethics Committee approval has been granted by Bellberry (2021-08-907).
Study findings will be disseminated in a peer-reviewed journal and at academic conferences.
NCT05344170.