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一项关于20:1大麻二酚:Δ9-四氢大麻酚医用大麻产品对神经认知、注意力和情绪影响的随机、安慰剂对照、双盲、交叉试验。

A randomised, placebo-controlled, double blind, crossover trial on the effect of a 20:1 cannabidiol: Δ9-tetrahydrocannabinol medical cannabis product on neurocognition, attention, and mood.

作者信息

Manning Brooke, Hayley Amie C, Catchlove Sarah, Stough Con, Downey Luke A

机构信息

Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Australia.

Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Australia; International Council for Alcohol, Drugs, and Traffic Safety (ICADTS), Rotterdam, the Netherland; Institute for Breathing and Sleep (IBAS), Austin Health, Melbourne Australia.

出版信息

Eur Neuropsychopharmacol. 2024 May;82:35-43. doi: 10.1016/j.euroneuro.2024.02.002. Epub 2024 Mar 14.

Abstract

As cannabinoid-based medications gain popularity in the treatment of refractory medical conditions, it is crucial to examine the neurocognitive effects of commonly prescribed products to ensure associated safety profiles. The present study aims to investigate the acute effects of a standard 1 mL sublingual dose of CannEpil®, a medicinal cannabis oil containing 100 mg cannabidiol (CBD) and 5 mg Δ9-tetrahydrocannabinol (THC) on neurocognition, attention, and mood. A randomised, double-blind, placebo-controlled, within-subjects design assessed 31 healthy participants (16 female, 15 male), aged between 21 and 58 years, over a two-week experimental protocol. Neurocognitive performance outcomes were assessed using the Cambridge Neuropsychological Test Automated Battery, with the Profile of Mood States questionnaire, and the Bond-Lader Visual Analogue Scale used to assess subjective state and mood. CannEpil increased Total Errors in Spatial Span and Correct Latency (median) in Pattern Recognition Memory, while also increasing Efficiency Score (lower score indicates greater efficiency) relative to placebo (all p < .05). Subjective Contentedness (p < .01) and Amicability (p < .05) were also increased at around 2.5 h post dosing, relative to placebo. Drowsiness or sedative effect was reported by 23 % of participants between three to six hours post CannEpil administration. Plasma concentrations of CBD, THC, and their metabolites were not significantly correlated with any observed alterations in neurocognition, subjective state, or adverse event occurrence. An acute dose of CannEpil impairs select aspects of visuospatial working memory and delayed pattern recognition, while largely preserving mood states among healthy individuals. Intermittent reports of drowsiness and sedation underscore the inter-individual variability of medicinal cannabis effects on subjective state. (ANZCTR; ACTRN12619000932167; https://www.anzctr.org.au).

摘要

随着基于大麻素的药物在难治性疾病治疗中越来越受欢迎,检查常用处方药的神经认知效应以确保相关安全性至关重要。本研究旨在调查标准1毫升舌下剂量的CannEpil®(一种含有100毫克大麻二酚(CBD)和5毫克Δ9-四氢大麻酚(THC)的药用大麻油)对神经认知、注意力和情绪的急性影响。一项随机、双盲、安慰剂对照的受试者内设计,在为期两周的实验方案中评估了31名年龄在21至58岁之间的健康参与者(16名女性,15名男性)。使用剑桥神经心理测试自动成套测验评估神经认知表现结果,并用情绪状态剖面图问卷以及邦德-莱德视觉模拟量表评估主观状态和情绪。与安慰剂相比,CannEpil增加了空间广度任务中的总错误数以及模式识别记忆中的正确潜伏期(中位数),同时还提高了效率得分(得分越低表明效率越高)(所有p < 0.05)。与安慰剂相比,给药后约2.5小时时主观满足感(p < 0.01)和友善性(p < 0.05)也有所增加。23%的参与者在服用CannEpil后三至六小时报告有嗜睡或镇静作用。CBD、THC及其代谢物的血浆浓度与任何观察到的神经认知、主观状态或不良事件发生的改变均无显著相关性。一剂急性剂量的CannEpil会损害视觉空间工作记忆和延迟模式识别的某些方面,同时在很大程度上保持健康个体的情绪状态。关于嗜睡和镇静的间歇性报告强调了药用大麻对主观状态影响的个体间差异。(澳大利亚和新西兰临床试验注册中心;ACTRN12619000932167;https://www.anzctr.org.au)

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