Changing the Tone of Clinical Study Design in the Cannabis Industry
The latest cannabis research from KGK Science has been published in the premier research journal, Translational Neuroscience. “Changing the tone of clinical study design in the cannabis industry” focuses on the need for synchronization of the circadian rhythms of study populations when designing clinical studies for demonstrating how cannabis health products can impact health and wellness.
Written by the leading research team at KGK Science, the paper presents evidence to support the influence of circadian rhythms on the levels of endocannabinoids, which in turn regulate the clinical efficacy of cannabinoids, specifically THC and CBD. “…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.” (Antony et al., Translational Neuroscience, 2020).
As a leading contract research organization conducting human clinical trials for the cannabis industry, KGK’s research notes that few placebo-controlled clinical studies currently examine the plasma or serum level of endocannabinoids after administering healthy participants with THC, resulting in a lack of information regarding the acute effects of THC on endocannabinoids in humans. While importance has been placed on the influence of the circadian rhythm on tissue homeostasis, sleep regulation, and behavior in the pharmaceutical industry, this has not been mirrored in the natural health and dietary supplement industries, leading to a gap in clinical trial design.
Read the full research paper for more details on this new research from KGK Science.
Changing the tone of clinical study design in the cannabis industry
Joseph M Antony, Alison C. McDonald, Farshid Noorbakhsh, Najla Guthrie and Mal Evans
Translational Neuroscience | Volume 11: Issue 1
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