评估夜间给予口服大麻药物的失眠患者次日可能出现的损害:一项先导随机对照试验。

Evaluating possible 'next day' impairment in insomnia patients administered an oral medicinal cannabis product by night: a pilot randomized controlled trial.

机构信息

Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Macquarie University, Sydney, Australia.

Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, Australia.

出版信息

Psychopharmacology (Berl). 2024 Sep;241(9):1815-1825. doi: 10.1007/s00213-024-06595-9. Epub 2024 May 17.

Abstract

Cannabis and its major constituents, Δ-tetrahydrocannabinol (THC) and cannabidiol (CBD), are being widely used to treat sleep disturbances. However, THC can cause acute cognitive and psychomotor impairment and there are concerns that driving and workplace safety might be compromised the day after evening use. Here, we examined possible 'next day' impairment following evening administration of a typical medicinal cannabis oil in adults with insomnia disorder, compared to matched placebo. This paper describes the secondary outcomes of a larger study investigating the effects of THC/CBD on insomnia disorder. Twenty adults [16 female; mean (SD) age, 46.1 (8.6) y] with physician-diagnosed insomnia who infrequently use cannabis completed two 24 h in-laboratory visits involving acute oral administration of combined 10 mg THC and 200 mg CBD ('THC/CBD') or placebo in a randomised, double-blind, crossover trial design. Outcome measures included 'next day' (≥9 h post-treatment) performance on cognitive and psychomotor function tasks, simulated driving performance, subjective drug effects, and mood. We found no differences in 'next day' performance on 27 out of 28 tests of cognitive and psychomotor function and simulated driving performance relative to placebo. THC/CBD produced a small decrease (-1.4%, p=.016, d=-0.6) in accuracy on the Stroop-Colour Task (easy/congruent) but not the Stroop-Word Task (hard/incongruent). THC/CBD also produced a small increase (+8.6, p=.042, d=0.3) in self-ratings of Sedated at 10 h post-treatment, but with no accompanying changes in subjective ratings of Alert or Sleepy (p's>0.05). In conclusion, we found a lack of notable 'next day' impairment to cognitive and psychomotor function and simulated driving performance following evening use of 10 mg oral THC, in combination with 200 mg CBD, in an insomnia population who infrequently use cannabis.

摘要

大麻及其主要成分 Δ-四氢大麻酚(THC)和大麻二酚(CBD)被广泛用于治疗睡眠障碍。然而,THC 可导致急性认知和运动功能损害,并且人们担心夜间使用后次日的驾驶和工作场所安全可能会受到影响。在这里,我们研究了与匹配的安慰剂相比,在患有失眠症的成年人中,每晚使用典型医用大麻油后可能出现的“次日”损害。本文描述了一项更大规模的研究的次要结果,该研究调查了 THC/CBD 对失眠症的影响。20 名成年人[16 名女性;平均(SD)年龄 46.1(8.6)岁]经医生诊断患有失眠症,且大麻使用频率较低,他们在 24 小时内完成了两次实验室就诊,包括口服联合使用 10 mg THC 和 200 mg CBD(“THC/CBD”)或安慰剂,采用随机、双盲、交叉试验设计。结果测量包括认知和运动功能测试、模拟驾驶表现、主观药物效应和情绪的“次日”(治疗后≥9 小时)表现。我们发现,与安慰剂相比,在 28 项认知和运动功能以及模拟驾驶表现测试中的 27 项测试中,次日表现没有差异。THC/CBD 使 Stroop-Colour 任务(简单/一致)的准确性降低(-1.4%,p=.016,d=-0.6),但 Stroop-Word 任务(困难/不一致)的准确性没有降低(p>.05)。THC/CBD 还使 10 小时后自我评估的 Sedated 评分升高(+8.6,p=.042,d=0.3),但 Alert 或 Sleepy 的主观评分没有变化(p>.05)。总之,我们发现,在经常使用大麻的失眠人群中,每晚使用 10 mg 口服 THC 与 200 mg CBD 联合使用后,对认知和运动功能以及模拟驾驶表现没有明显的次日损害。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c090/11339085/9ad14787607a/213_2024_6595_Fig1_HTML.jpg

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