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3
A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.一项在健康志愿者中进行的单次口服油溶液和单次及多次舌下片剂给予的大麻二酚的安全性、耐受性和药代动力学的 I 期临床试验。
Br J Clin Pharmacol. 2021 Apr;87(4):2070-2077. doi: 10.1111/bcp.14617. Epub 2020 Nov 18.
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A single dose of cannabidiol modulates medial temporal and striatal function during fear processing in people at clinical high risk for psychosis.单次剂量的大麻二酚可调节临床精神病高危人群在恐惧处理过程中的内侧颞叶和纹状体功能。
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A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers.一项1期随机、安慰剂对照、剂量递增研究,旨在调查食源性健康志愿者中大麻二酚的安全性、耐受性和药代动力学。
Eur J Drug Metab Pharmacokinet. 2020 Oct;45(5):575-586. doi: 10.1007/s13318-020-00624-6.
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The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.健康男性连续七天急性和持续服用大麻二酚对血流动力学的影响:一项随机对照试验。
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J Psychopharmacol. 2019 Sep;33(9):1141-1148. doi: 10.1177/0269881119858306. Epub 2019 Jun 25.

大麻二酚对健康成年人主观状态、认知和精神运动功能的影响:一项随机临床试验。

The effects of cannabidiol on subjective states, cognition, and psychomotor function in healthy adults: A randomized clinical trial.

机构信息

Department of Epidemiology and Biostatistics, West Virginia University, Morgantown, West Virginia, USA.

Department of Family Medicine, West Virginia University, Morgantown, West Virginia, USA.

出版信息

Fundam Clin Pharmacol. 2023 Jun;37(3):663-672. doi: 10.1111/fcp.12868. Epub 2023 Jan 17.

DOI:10.1111/fcp.12868
PMID:36625844
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10175152/
Abstract

Despite being added to numerous products, little is known about cannabidiol. Drowsiness is a self-reported side effect, which could impact cognitive functioning. To determine whether cannabidiol impacts cognition and psychomotor function, a volunteer sample of healthy, college students were recruited for this randomized, parallel-group, double-blind, feasibility trial from April-November 2021. Participants completed a baseline survey, the Stanford Sleepiness Scale, Visual Analog Mood Scale, Digit Symbol Substitution Test, Trail Making Test, Psychomotor Vigilance Test, and Simple Reaction Time Tests. Participants were then randomized and allocated to receive 300 mg cannabidiol oil (N = 21) or placebo (N = 19). After 120 min, participants retook the tests. Performance between groups was compared using Analysis of Covariance and multi-level Negative Binomial regression. Participants averaged 21 ± 3 years of age, and 52% were female. Self-reported anxiety did not change posttreatment. Performances on the Stanford Sleepiness Scale, Visual Analog Mood Scale, and Psychomotor Vigilance Test increased for both groups. After accounting for baseline scores, attention lapse duration significantly increased for those receiving cannabidiol compared to placebo in the Psychomotor Vigilance Test (76 vs. 66 ms; p = 0.02). Auditory reaction time improved in the cannabidiol group versus placebo for one sound emitted during the Simple Reaction Time Test (241 vs. 245 ms; p = 0.02), but the number of early responses increased from 0.3 to 0.8 for those receiving cannabidiol. While performance on most tests was similar between those receiving cannabidiol and placebo, cannabidiol might affect certain aspects of vigilance. More research and larger trials are needed.

摘要

尽管大麻二酚已被添加到许多产品中,但人们对其知之甚少。嗜睡是一种自述的副作用,可能会影响认知功能。为了确定大麻二酚是否会影响认知和精神运动功能,我们从 2021 年 4 月至 11 月招募了一批健康的大学生志愿者,进行了这项随机、平行组、双盲、可行性试验。参与者完成了基线调查、斯坦福嗜睡量表、视觉模拟情绪量表、数字符号替代测试、连线测试 A 和 B、精神运动警觉测试和简单反应时测试。然后,参与者被随机分配并接受 300 毫克大麻二酚油(N=21)或安慰剂(N=19)。120 分钟后,参与者重新进行了测试。使用协方差分析和多层次负二项回归比较了组间的表现。参与者的平均年龄为 21±3 岁,52%为女性。治疗后,自我报告的焦虑没有变化。两组的斯坦福嗜睡量表、视觉模拟情绪量表和精神运动警觉测试的得分均有所提高。在考虑基线得分后,接受大麻二酚治疗的人的精神运动警觉测试中注意力不集中的持续时间明显长于安慰剂组(76 与 66 毫秒;p=0.02)。与安慰剂组相比,接受大麻二酚治疗的人在简单反应时测试中听到一个声音时的听觉反应时间有所改善(241 与 245 毫秒;p=0.02),但接受大麻二酚治疗的人的早期反应次数从 0.3 增加到 0.8。尽管接受大麻二酚和安慰剂的人在大多数测试中的表现相似,但大麻二酚可能会影响警觉的某些方面。需要进一步的研究和更大规模的试验。