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四氢大麻酚主观精神和躯体效应的量化及时间进程——一项针对健康志愿者的前瞻性、单盲、安慰剂对照探索性试验

Quantification and time course of subjective psychotropic and somatic effects of tetrahydrocannabinol - a prospective, single-blind, placebo-controlled exploratory trial in healthy volunteers.

作者信息

Kleine-Brueggeney Maren, Huber Markus, Theiler Lorenz, Priemer Fritz, Greif Robert

机构信息

Deutsches Herzzentrum der Charité (DHZC), Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Statistician, Department of Anaesthesiology and Pain Medicine, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.

出版信息

BMC Psychiatry. 2024 Dec 18;24(1):902. doi: 10.1186/s12888-024-06338-2.

Abstract

BACKGROUND

Cannabis is increasingly used and debates about the legalisation of the recreational use of cannabis are ongoing. In this prospective, placebo-controlled study in healthy volunteers not regularly consuming cannabis, subjective psychotropic and somatic effects after a single dose of intravenous THC were assessed and quantified over 48 h.

METHODS

Twenty-five healthy volunteers received a single IV bolus of THC and 6 received normal saline. Psychotropic and somatic effects of THC were assessed by two questionnaires that were completed at up to 14 timepoints from shortly before drug administration to 48 h later.

RESULTS

Demographic data did not differ between groups. Differences between THC and placebo for all assessed effects, except for euphoria, irritation and headache, were clearly discernible. Subdimensions related to positive mood were less and those related to negative mood were more pronounced in the THC group. Peak plasma concentrations were observed at 1 to 5 min after THC administration while peak effects occurred between 45 and 60 min. Differences between THC and placebo were pronounced and seen for up to 90 to 120 min for most effects, except for "sleepiness" and "deactivation", where the effect of THC was discernible for up to 5 h. At 24 and 48 h, there were no statistically significant difference between THC and placebo group.

CONCLUSIONS

THC triggers a large range of psychotropic and somatic effects with peak effects at 45 to 60 min after IV administration of THC, much later than plasma peak levels. Most effects are short-lasting with a duration of up to 2 h, but some effects like sleepiness and deactivation can be longer-lasting and persist for 5 h or longer in cannabis-naïve or cannabis-abstinent individuals. Since effects of THC demonstrate a time course that differs from the time course of plasma concentrations it might be important to base the judgment of a possible impairment related to THC consumption on clinical or behavioral tests in addition to THC plasma levels.

TRIAL REGISTRATION

www.isrctn.com ; registration number ISRCTN53019164.

摘要

背景

大麻的使用日益增加,关于娱乐性使用大麻合法化的辩论仍在进行。在这项针对不经常使用大麻的健康志愿者的前瞻性、安慰剂对照研究中,评估并量化了单次静脉注射四氢大麻酚(THC)后48小时内的主观精神和躯体效应。

方法

25名健康志愿者接受了单次静脉推注THC,6名接受了生理盐水。通过两份问卷评估THC的精神和躯体效应,这两份问卷在给药前不久至给药后48小时内的多达14个时间点完成。

结果

两组之间的人口统计学数据没有差异。除了欣快感、易怒和头痛外,THC与安慰剂在所有评估效应上的差异都很明显。与积极情绪相关的子维度在THC组中较少,而与消极情绪相关的子维度更明显。THC给药后1至5分钟观察到血浆峰值浓度,而峰值效应出现在45至60分钟之间。THC与安慰剂之间的差异很明显,大多数效应在90至120分钟内可见,除了“嗜睡”和“失活”,THC的效应在长达5小时内都可察觉。在24小时和48小时时,THC组和安慰剂组之间没有统计学上的显著差异。

结论

THC引发了一系列精神和躯体效应,静脉注射THC后45至60分钟达到峰值效应,比血浆峰值水平晚得多。大多数效应持续时间较短,长达2小时,但一些效应如嗜睡和失活在未接触过大麻或已戒除大麻的个体中可能持续时间更长,持续5小时或更长时间。由于THC的效应显示出与血浆浓度的时间进程不同,除了THC血浆水平外,基于临床或行为测试来判断与THC消费相关的可能损害可能很重要。

试验注册

www.isrctn.com;注册号ISRCTN53019164。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/259e/11654089/5d8f4a42972b/12888_2024_6338_Fig2_HTML.jpg

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