Assessing the Effects of a Cannabidiol Derived From Hemp Supplement in Healthy Adults
Condition: Healthy; Safety Issues
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Cannabinol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Prospective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects.; Prospective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between subjects study design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other