INTERVENTIONALCOMPLETEDNCT05212402

A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Physiological, Biochemical, and Psychometric Impacts of a Brand-Specific Hemp-Derived Cannabidiol Product in Healthy Adults

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-11-01

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: NA
Enrollment: 56 (ACTUAL)
Start date: 2022-01-18
Sponsor: University of South Carolina
Design: RANDOMIZED · PARALLEL · OTHER
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Cannabinol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DIETARY SUPPLEMENT

Cannabinol

Prospective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects.

OTHER

Placebo

Prospective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepted

Inclusion criteria

body mass index of 19.0 to 34.9 kg/m2 (normal weight through Class I obesity)
Agree to refrain from alcohol consumption for at least 48 hours prior to each visit.
Willing to practice acceptable measures of birth control and sexually transmitted infections prevention by using double-barrier contraceptive measures (both males and females) throughout the study duration.
Willing and able to agree to the requirements and restrictions of this study including fasting before blood draw on all visits for laboratory assessment.
Willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow any study related evaluations.

Exclusion criteria

Have a known sensitivity or allergy to any of the investigational products or their ingredients.
Female participants who are lactating, pregnant or planning to become pregnant during the study as confirmed at the baseline (visit 2) or male participants of reproductive potential in a heterosexual relationship planning a pregnancy as confirmed at the baseline visit.
Documented medical history of immune disorder (such as Human immunodeficiency Virus/Acquired immunodeficiency syndrome), hepatitis B or hepatitis C, or reported immune disorder diagnosis.
Active psychiatric disorder requiring hospitalization within the 12 months prior to screening or currently on medication(s) to treat any psychiatric disorder(s).
Any cognitive impairment that would, in the opinion of the Investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer's, dementia).
History of malignancy or those with any first-degree relatives with a history of cancer (e.g., familial cancer disorders) within 5 years.
History of clinically significant cardiovascular, respiratory, renal, cerebrovascular, metabolic, pulmonary, gastrointestinal, neurological, hematological, autoimmune, lymphatic, psychiatric, chronic pain and sleep disorders, hepatobiliary (with the exception of Gilbert's syndrome or asymptomatic gallstones) or endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the Investigator, may preclude safe study participation.

primary outcomes