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Changing the Tone of Clinical Study Design in the Cannabis Industry.
Translational Neuroscience ( IF 1.8 ) Pub Date : 2020-02-13 , DOI: 10.1515/tnsci-2020-0002
Joseph M Antony 1 , Alison C McDonald 1 , Farshid Noorbakhsh 2 , Najla Guthrie 1 , Mal Evans 1
Affiliation  

Cannabis (also known as marijuana) is the most frequently used psychoactive substance globally. Cannabis exerts therapeutic functions for many indications and has vast potential as a health and wellness product. Advances in our understanding of the composition and pharmacological properties of cannabis have revealed interactions between cannabis, an individuals’ circadian rhythms and their endocannabinoid signaling. Exogenously administered cannabinoids can bidirectionally entrain central and peripheral clocks that comprise circadian rhythms, and malfunctions in the endocannabinoid system are reported to impact neurological processes. Therefore, it is necessary to account for the circadian rhythm when designing clinical trials examining the pharmacological properties of cannabis-based products for health and wellness to limit its potential confounding impact on results. Consideration of the entrainment capabilities of the endocannabinoid system is warranted when designing clinical trials.

中文翻译:

改变大麻行业临床研究设计的基调。

大麻(也称为大麻)是全球最常用的精神活性物质。大麻具有多种适应症的治疗功能,具有作为保健产品的巨大潜力。在我们对大麻的组成和药理特性的理解上的进步揭示了大麻,个体的昼夜节律及其内源性大麻素信号之间的相互作用。外用大麻素可双向夹带包含昼夜节律的中央和周边时钟,据报道,内源性大麻素系统功能异常会影响神经系统过程。因此,在设计临床试验以检查基于大麻的产品对健康和保健的药理特性时,有必要考虑到昼夜节律,以限制其对结果的潜在混杂影响。设计临床试验时,必须考虑内源性大麻素系统的夹带能力。
更新日期:2020-02-13
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