HealthyNCT05212402
Assessing the Effects of a Cannabidiol Derived From Hemp Supplement in Healthy Adults
A study testing Cannabinol in people with Healthy and Safety Issues, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Safety Issues
- What is being tested?
- Cannabinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Participants with controlled or uncontrolled hypertension including stage 1 hypertension (systolic blood pressure ≥129 mmHg and diastolic blood pressure ≥89 mmHg).
- Participants who are on medications as prescribed for any of the aforementioned exclusionary criteria. Participants on stable dose of thyroid medication (no dosage changes within last 3 months) are acceptable.
- Consumption of prescription or non-prescription: angiotensin converting enzyme inhibitors, angiotensin receptor blockers, barbiturates, cocaine, ethanol, selective serotonin reuptake inhibitor, protease inhibitors, warfarin, sildenafil, theophylline, tricyclic antidepressants and any other medications
- Receipt or use of an investigational product in another research study within 30 days or 5 half lives (whichever is longer) prior to baseline (visit 2) or currently participating in another study
- Receipt or use of an investigational product in another research study within 30 days or 5 half lives (whichever is longer) prior to baseline (visit 2) or currently participating in another study
- Current or recent use (within one month prior to visit 2) of cannabis (e.g., marijuana) or cannabis related products (e.g., CBD) in any ingestible or inhalable forms.
- Positive urine drug test for THC or drugs of abuse (Amphetamine, cocaine, marijuana, methamphetamine, and opiates) at baseline (visit 2).
- Safety blood tests at screening more than 2 times the upper limit of normal (ULN) for liver or kidney function tests.
- Safety blood tests at screening more than 2 times the upper limit of normal (ULN) for liver or kidney function tests.
- Fasting blood glucose of ≥160 mg/dL (after a repeat that confirms the original result) at screening.
- Any other condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Sport Science Lab
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Safety Issues
- Being tested
- Cannabinol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabinolDietary supplement
Prospective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects.
PlaceboOther
Prospective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects.
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | 28 participants will be given the test product (TP) Receives: Dietary Supplement: Cannabinol |
| Placebo | Placebo comparator | 28 participants will be given the placebo product. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in angiotensin-renin converting enzyme (ACE)
To determine if the test product (TP) has any effect on the activity of angiotensin-renin converting enzyme (ACE) compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in white blood cell count
To determine if the TP has an impact on white blood cell count compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in red blood cell count
To determine if the TP has an impact on red blood cell count compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in hemoglobin
To determine if the TP has an impact on hemoglobin compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in hematocrit
To determine if the TP has an impact on hematocrit compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in mean corpuscular volume
To determine if the TP has an impact on mean corpuscular volume compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in mean corpuscular hemoglobin concentration
To determine if the TP has an impact on mean corpuscular hemoglobin concentration compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in red blood cell distribution width
To determine if the TP has an impact on red blood cell distribution width concentration compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in platelet count
To determine if the TP has an impact on platelet count compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in mean platelet volume
To determine if the TP has an impact on mean platelet volume compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in absolute and relative neutrophils
To determine if the TP has an impact on absolute and relative neutrophils compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in absolute and relative lymphocytes
To determine if the TP has an impact on absolute and relative lymphocytes compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in absolute and relative monocytes
To determine if the TP has an impact on absolute and relative monocytes compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in absolute and relative eosinophils
To determine if the TP has an impact on absolute and relative eosinophils compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in absolute and relative basophils
To determine if the TP has an impact on absolute and relative basophils compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in TNF-alpha
To determine if the TP has an impact on TNF-alpha compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in interleukin-6
To determine if the TP has an impact on interleukin-6 compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in interleukin-10
To determine if the TP has an impact on interleukin-10 compared to placebo
Measured: Baseline, Month 1, Month 2, Month 3
Changes in cold and flu prevalence
To determine if the TP has an impact on number of days of lost productivity (days taken off from work or school) due to cold/flu symptoms compared to placebo
Measured: Baseline, Month 3
Changes in subjective stress levels
To determine if the TP has an impact on stress levels assessed by Cohen's perceived stress scale compared to placebo. The minimum value is 0 and the maximum value is 40. Higher scores mean a worse outcome.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in sleep quality
To determine if the TP has an impact on sleep quality assessed by Pittsburgh Sleep Quality Index compared to placebo. The minimum score is 0 and the maximum score is 40. Higher scores mean a worse outcome.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in total mood disturbances
To determine if the TP has an impact on total mood disturbance assessed by the Profile of Mood States (POMS) compared to placebo The total mood is calculated by adding the negative subscales (tension, depression, fatigue, confusion, and anger) subtracting the positive subscales (vigor, esteem-related affect).
Measured: Baseline, Month 1, Month 2, Month 3
Changes in fatigue-inertia
To determine if the TP has an impact on fatigue-inertia (POMS sub-score) compared to placebo. Min 0, Max 28, higher scores may be associated with worse outcomes.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in anger-hostility
To determine if the TP has an impact on anger-hostility (POMS sub-score) compared to placebo. Min 0, max 48, higher scores are associated with worse outcomes.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in vigor-activity
To determine if the TP has an impact on vigor-activity (POMS sub-score) compared to placebo. Min 0, max 32, higher scores are associated with better outcomes.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in confusion-bewilderment
To determine if the TP has an impact on confusion-bewilderment (POMS sub-score) compared to placebo. Min 0, max 28, and higher scores are associated with worse outcomes.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in depression-dejection
To determine if the TP has an impact on depression-dejection (POMS sub-score) compared to placebo. Min 0, max 60, and higher scores are associated with worse outcomes.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in tension-anxiety
To determine if the TP has an impact on tension-anxiety (POMS sub-score) compared to placebo. Min 0, max 60, higher scores are associated with worse outcomes.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in Overall Body Pain/Discomfort Scale
To determine if the TP has an impact on body pain and discomfort assessed by the Overall Body Pain/Discomfort Scale compared to placebo, which is a validated dually anchored Likert 10-point scale. Min value is 0, the max is 10, and a higher value is a worse outcome.
Measured: Baseline, Month 1, Month 2, Month 3
Changes in foundation pain
To determine if the TP has an impact on foundation pain index which is calculated from urinalysis compared to placebo. Min 0 and Max 100, higher scores indicate worse outcomes.
Measured: Baseline, Month 1, Month 2, Month 3
Secondary outcomes (13)
Changes in AST as a marker of liver function
To determine if the TP has an impact on serum AST as a marker of liver function assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in ALT as a marker of liver function
To determine if the TP has an impact on serum ALT as a marker of liver function assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in alkaline phosphatase as a marker of liver function
To determine if the TP has an impact on serum alkaline phosphatase as a marker of liver function assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in creatinine as a marker of kidney function
To determine if the TP has an impact on creatinine as a marker of kidney function assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in potassium as a marker of kidney function
To determine if the TP has an impact on potassium as a marker of kidney function assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in blood urea nitrogen as a marker of kidney function
To determine if the TP has an impact on blood urea nitrogen as a marker of kidney function assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in blood glucose
To determine if the TP has an impact on blood glucose assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in electrolyte balance
To determine if the TP has an impact on electrolyte balance assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in serum albumin
To determine if the TP has an impact on serum albumin assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in serum albumin/globulin ratio
To determine if the TP has an impact on serum albumin/globulin ratio assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in total serum bilirubin serum
To determine if the TP has an impact on total bilirubin assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in total serum protein
To determine if the TP has an impact on total serum protein assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Changes in blood urea nitrogen
To determine if the TP has an impact on blood urea nitrogen assessed using a comprehensive metabolic panel compared to placebo
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start18 Jan 2022
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between subjects study design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Principal investigator, Shawn M. Arent, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212402
- Sponsor's protocol ID
- Pro00115662
- Status last verified
- Oct 2022
- First submitted
- 6 Dec 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05212402
- Acronym / sponsor ID
- Pro00115662
- Conditions
- Healthy, Safety Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Between subjects study design.
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Dietary Supplement: Cannabinol28 participants will be given the test product (TP) |
| Placebo | Placebo comparator | Other: Placebo28 participants will be given the placebo product. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabinolProspective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects. | Dietary supplement | Test Product |
| PlaceboProspective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects. | Other | Placebo |
Primary outcome
Changes in angiotensin-renin converting enzyme (ACE)
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the test product (TP) has any effect on the activity of angiotensin-renin converting enzyme (ACE) compared to placebo
Changes in white blood cell count
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on white blood cell count compared to placebo
Changes in red blood cell count
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on red blood cell count compared to placebo
Changes in hemoglobin
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on hemoglobin compared to placebo
Changes in hematocrit
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on hematocrit compared to placebo
Changes in mean corpuscular volume
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on mean corpuscular volume compared to placebo
Changes in mean corpuscular hemoglobin concentration
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on mean corpuscular hemoglobin concentration compared to placebo
Changes in red blood cell distribution width
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on red blood cell distribution width concentration compared to placebo
Changes in platelet count
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on platelet count compared to placebo
Changes in mean platelet volume
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on mean platelet volume compared to placebo
Changes in absolute and relative neutrophils
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on absolute and relative neutrophils compared to placebo
Changes in absolute and relative lymphocytes
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on absolute and relative lymphocytes compared to placebo
Changes in absolute and relative monocytes
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on absolute and relative monocytes compared to placebo
Changes in absolute and relative eosinophils
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on absolute and relative eosinophils compared to placebo
Changes in absolute and relative basophils
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on absolute and relative basophils compared to placebo
Changes in TNF-alpha
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on TNF-alpha compared to placebo
Changes in interleukin-6
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on interleukin-6 compared to placebo
Changes in interleukin-10
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on interleukin-10 compared to placebo
Changes in cold and flu prevalence
Time frame: Baseline, Month 3
To determine if the TP has an impact on number of days of lost productivity (days taken off from work or school) due to cold/flu symptoms compared to placebo
Changes in subjective stress levels
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on stress levels assessed by Cohen's perceived stress scale compared to placebo. The minimum value is 0 and the maximum value is 40. Higher scores mean a worse outcome.
Changes in sleep quality
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on sleep quality assessed by Pittsburgh Sleep Quality Index compared to placebo. The minimum score is 0 and the maximum score is 40. Higher scores mean a worse outcome.
Changes in total mood disturbances
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on total mood disturbance assessed by the Profile of Mood States (POMS) compared to placebo The total mood is calculated by adding the negative subscales (tension, depression, fatigue, confusion, and anger) subtracting the positive subscales (vigor, esteem-related affect).
Changes in fatigue-inertia
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on fatigue-inertia (POMS sub-score) compared to placebo. Min 0, Max 28, higher scores may be associated with worse outcomes.
Changes in anger-hostility
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on anger-hostility (POMS sub-score) compared to placebo. Min 0, max 48, higher scores are associated with worse outcomes.
Changes in vigor-activity
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on vigor-activity (POMS sub-score) compared to placebo. Min 0, max 32, higher scores are associated with better outcomes.
Changes in confusion-bewilderment
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on confusion-bewilderment (POMS sub-score) compared to placebo. Min 0, max 28, and higher scores are associated with worse outcomes.
Changes in depression-dejection
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on depression-dejection (POMS sub-score) compared to placebo. Min 0, max 60, and higher scores are associated with worse outcomes.
Changes in tension-anxiety
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on tension-anxiety (POMS sub-score) compared to placebo. Min 0, max 60, higher scores are associated with worse outcomes.
Changes in Overall Body Pain/Discomfort Scale
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on body pain and discomfort assessed by the Overall Body Pain/Discomfort Scale compared to placebo, which is a validated dually anchored Likert 10-point scale. Min value is 0, the max is 10, and a higher value is a worse outcome.
Changes in foundation pain
Time frame: Baseline, Month 1, Month 2, Month 3
To determine if the TP has an impact on foundation pain index which is calculated from urinalysis compared to placebo. Min 0 and Max 100, higher scores indicate worse outcomes.
13 secondary outcomes
Changes in AST as a marker of liver function
Time frame: Baseline, Month 3
Changes in ALT as a marker of liver function
Time frame: Baseline, Month 3
Changes in alkaline phosphatase as a marker of liver function
Time frame: Baseline, Month 3
Changes in creatinine as a marker of kidney function
Time frame: Baseline, Month 3
Changes in potassium as a marker of kidney function
Time frame: Baseline, Month 3
Changes in blood urea nitrogen as a marker of kidney function
Time frame: Baseline, Month 3
Changes in blood glucose
Time frame: Baseline, Month 3
Changes in electrolyte balance
Time frame: Baseline, Month 3
Changes in serum albumin
Time frame: Baseline, Month 3
Changes in serum albumin/globulin ratio
Time frame: Baseline, Month 3
Changes in total serum bilirubin serum
Time frame: Baseline, Month 3
Changes in total serum protein
Time frame: Baseline, Month 3
Changes in blood urea nitrogen
Time frame: Baseline, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabinol in people with Healthy and Safety Issues, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in angiotensin-renin converting enzyme (ACE) (time frame: Baseline, Month 1, Month 2, Month 3). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.