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两种口服形式的大麻二酚对健康志愿者情绪刺激反应的影响:药物载体很重要。

Effect of two oral formulations of cannabidiol on responses to emotional stimuli in healthy human volunteers: pharmaceutical vehicle matters.

机构信息

Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto (FMRP), Universidade de São Paulo (USP), Ribeirão Preto, SP, Brazil.

Instituto Nacional de Ciência e Tecnologia, Medicina Translacional (INCT-TM), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Ribeirão Preto, SP, Brazil.

出版信息

Braz J Psychiatry. 2022 Jan-Feb;44(1):15-20. doi: 10.1590/1516-4446-2020-1684.

Abstract

OBJECTIVE

To compare plasma concentrations of cannabidiol (CBD) following oral administration of two formulations of the drug (powder and dissolved in oil), and to evaluate the effects of these distinct formulations on responses to emotional stimuli in healthy human volunteers.

METHODS

In a randomized, double-blind, placebo-controlled, parallel-group design, 45 healthy male volunteers were randomly assigned to three groups of 15 subjects that received either 150 mg of CBD powder; 150 mg of CBD dissolved in corn oil; or placebo. Blood samples were collected at different times after administration, and a facial emotion recognition task was completed after 150 min.

RESULTS

There were no significant differences across groups in the subjective and physiological measures, nor in the facial emotion recognition task. However, groups that received the drug showed statistically significant differences in baseline measures of plasma CBD, with a significantly greater difference in favor of the oil formulation.

CONCLUSION

When administered as a single 150-mg dose, neither formulation of oral CBD altered responses to emotional stimuli in healthy subjects. The oil-based CBD formulation resulted in more rapid achievement of peak plasma level, with an approximate fourfold increase in oral bioavailability.

摘要

目的

比较两种药物制剂(粉末和溶于油中)口服后大麻二酚(CBD)的血浆浓度,并评估这两种不同制剂对健康人类志愿者对情绪刺激的反应的影响。

方法

在一项随机、双盲、安慰剂对照、平行组设计中,45 名健康男性志愿者随机分为三组,每组 15 名受试者,分别给予 150mg CBD 粉末;150mg CBD 溶于玉米油中;或安慰剂。给药后不同时间采集血样,150min 后完成面部情绪识别任务。

结果

各组在主观和生理测量以及面部情绪识别任务中均无显著差异。然而,接受药物的组在基线血浆 CBD 测量方面表现出统计学上的显著差异,油制剂的差异更显著。

结论

当作为单次 150mg 剂量给药时,两种口服 CBD 制剂均未改变健康受试者对情绪刺激的反应。基于油的 CBD 制剂可更快地达到血浆峰值水平,口服生物利用度约增加四倍。

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