The Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.
The Brain and Mind Centre, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2024 Mar 25;14(3):e082927. doi: 10.1136/bmjopen-2023-082927.
The non-intoxicating plant-derived cannabinoid, cannabidiol (CBD), has demonstrated therapeutic potential in a number of clinical conditions. Most successful clinical trials have used relatively high (≥300 mg) oral doses of CBD. Relatively few studies have investigated the efficacy of lower (<300 mg) oral doses, typical of those available in over-the-counter CBD products.
We present a protocol for a randomised, double-blind, placebo-controlled, parallel-group clinical trial investigating the effects of a low oral dose (150 mg) of CBD on acute psychosocial stress, situational anxiety, motion sickness and cybersickness in healthy individuals. Participants (n=74) will receive 150 mg of CBD or a matched placebo 90 min before completing three virtual reality (VR) challenges (tasks) designed to induce transient stress and motion sickness: (a) a 15 min 'Public Speaking' task; (b) a 5 min 'Walk the Plank' task (above a sheer drop); and (c) a 5 min 'Rollercoaster Ride' task. The primary outcomes will be self-reported stress and nausea measured on 100 mm Visual Analogue Scales. Secondary outcomes will include salivary cortisol concentrations, skin conductance, heart rate and vomiting episodes (if any). Statistical analyses will test the hypothesis that CBD reduces nausea and attenuates subjective, endocrine and physiological responses to stress compared with placebo. This study will indicate whether low-dose oral CBD has positive effects in reducing acute psychosocial stress, situational anxiety, motion sickness and cybersickness.
The University of Sydney Human Research Ethics Committee has granted approval (2023/307, version 1.6, 16 February 2024). Study findings will be disseminated in a peer-reviewed journal and at academic conferences.
Australian New Zealand Clinical Trials Registry (ACTRN12623000872639).
非致醉型植物源大麻素，大麻二酚（CBD），在多种临床病症中显示出治疗潜力。大多数成功的临床试验都使用了相对较高（≥300mg）的口服 CBD 剂量。相对较少的研究调查了较低（<300mg）口服剂量的疗效，这些剂量通常存在于非处方 CBD 产品中。
我们提出了一项随机、双盲、安慰剂对照、平行组临床试验方案，旨在研究低剂量（150mg）口服 CBD 对健康个体急性心理社会应激、情境性焦虑、晕动病和网络晕动病的影响。参与者（n=74）将在完成三个旨在诱导短暂应激和晕动病的虚拟现实（VR）挑战（任务）前 90 分钟接受 150mg CBD 或匹配的安慰剂：（a）15 分钟的“公开演讲”任务；（b）5 分钟的“走木板”任务（在陡峭的落差上方）；（c）5 分钟的“过山车骑行”任务。主要结局将是在 100mm 视觉模拟量表上自我报告的应激和恶心程度。次要结局将包括唾液皮质醇浓度、皮肤电导、心率和呕吐发作（如有）。统计分析将检验 CBD 与安慰剂相比是否能减轻恶心，并减轻主观、内分泌和生理对压力的反应这一假设。本研究将表明低剂量口服 CBD 是否具有减轻急性心理社会应激、情境性焦虑、晕动病和网络晕动病的积极作用。
悉尼大学人类研究伦理委员会已批准（2023/307，版本 1.6，2024 年 2 月 16 日）。研究结果将在同行评议的期刊和学术会议上发表。
澳大利亚和新西兰临床试验注册中心（ACTRN12623000872639）。
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