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Clinical Trial Summary

The purpose of this prospective, randomized, double-blind, placebo-controlled trial is to assess the physiological, biochemical, and psychometric impacts of a brand-specific hemp-derived cannabidiol product in a sample of healthy adults.


Clinical Trial Description

Cannabis contains several phyto-cannabinoids among which Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are most widely known. THC is the main compound responsible for the psychoactive properties and also deemed responsible for several side-effects associated with cannabis. CBD, on the other hand, is not a strong cannabinoid receptor agonist and lacks psychotropic activity. However, due to its affinity for several other target sites, it is being studied for potential pharmacological properties. The diverse range of interactions at different receptor sites in the human body is believed to be responsible for therapeutic efficacy of CBD in treating kidney fibrosis, metabolic syndrome, anorexia, obesity, amelioration of osteoarthritis as well as several other musculoskeletal diseases. Recent research has also explored the use of CBD to relieve stress and depression, likely due to its agonistic influence on the 5-HT3 receptors as well as improving hippocampal neural growth and development. CBD has also been studied for its anti-oxidant activity, deemed on-par to that of Vitamin C in laboratory studies. The effect of CBD on inflammation and the immune system has been studied. The sedative effects of CBD have been investigated for the potential use of CBD as an anxiolytic and to improve mood as well as sleep. Recent studies have also explored the analgesic and pain-relieving properties of CBD, making it a suitable candidate that needs further investigations. Interestingly, a recent systematic review explored the use of CBD in viral diseases, with several pre-clinical studies indicating CBD as an effective candidate against viral disease. With the spread of the coronavirus disease (COVID-19) pandemic, there has been a strong interest in developing therapies to eliminate or reduce the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. SARS-CoV-2 uses Angiotensin Converting Enzyme (ACE) receptors to gain entry into the human body and penetrate the respiratory system. In a recent in vitro study, pretreatment with CBD in cells expressing ACE-2 receptor was effective in inhibiting the replication of SARS-CoV-2 in those cells. This is an interesting finding where further research is needed to study the influence of CBD consumption on ACE activity. Several studies of CBD safety have demonstrated lack of any safety concerns over a range of different doses. A recent safety study of CBD by Bergamaschi et al. demonstrated absence of any influence on the central nervous system, vital signs or mood changes as well as lack of any side effect observed for doses up to 1500 mg/day (orally) or 30 mg/day (intravenously).It has been hypothesized that the trace amounts of THC present within the CBD extract could potentially be responsible for any side-effects. Therefore, CBD is considered very safe for human consumption in the dose being tested in this study (<200mg/day). Additional clinical research is required to confirm and support therapeutic use of CBD for being effective in modulating ACE expression, mood, stress, anti-inflammatory, antioxidant, immunomodulating, sedative & anxiolytic, analgesic, pain relieving and anti-viral therapeutic claims. This research will also help to understand any safety issues with the long-term regular use of CBD on healthy adults. Therefore, this prospective, randomized, double-blind, placebo controlled study will be conducted to explore the physiologic, biochemical, and psychometric impacts of a brand-specific hemp-derived CBD product in healthy adults. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05212402
Study type Interventional
Source University of South Carolina
Contact Shawn M Arent, PhD
Phone 8035768394
Email [email protected]
Status Recruiting
Phase N/A
Start date January 18, 2022
Completion date September 2022

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