Broad spectrum cannabinoid formulationPlacebo gel capsule
Broad spectrum cannabinoid formulation: Broad spectrum cannabinoid formulation gel capsule
Placebo gel capsule: Placebo gel capsule will have MCT oil only, no active ingredient
Study summary
The goal of this double-blind, placebo-controlled, cross over study is to learn about the neuroprotective properties of a broad-spectrum cannabinoid formulation in normal healthy adults engaged in elite contact sport competition.
The main question it aims to answer :
• Is the broad-spectrum cannabinoid formulation neuroprotective for athletes participating in competitive contact sports? Can this formulation facilitate recovery in those who suffer from concussion by reducing inflammation and/or reduce the number of concussions sustained without adverse physiological and psychological dysfunction when administered daily?
Participants will:
* be given a broad-spectrum cannabinoid gel capsule or a placebo twice daily.
* have blood samples taken to analyze pharmacokinetics and pharmacodynamics of cannabinoid metabolites, liver function, complete blood count and blood differential, inflammatory biomarkers and genetic analysis
* have stool samples collected for gut microbiome analysis;
* undergo testing sessions, which will include psychological and health questionnaires, equipment to record signals from the brain and heart, and safety laboratory tests.
Eligibility
Sex
MALE
Min age
19 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy male adults between 19-35 years of age that compete in contact sport athletics.
* Participants with no known cerebrovascular or cardiovascular complications.
* Participants will not be habitual recreational users of cannabis (i.e., \<1 day/week) or tobacco users.
* Participants that agree not use any other cannabis or tobacco products while enrolled in the study.
* Participants willing to provide a list of any prescription medications they are taking.
* Ability to maintain commitment to all proposed biopsychological and health questionnaires, and neuro-physiological, physiological, perceptual-cognitive, and functional motor skills laboratory tests.
* Participants who are capable of giving signed informed consent.
Exclusion Criteria:
* Female.
* Must not travel to the USA during study period; USA laws do not permit cross border with cannabis products.
* Use of cannabis-based therapy within 2 months (participants who have previously used a cannabis based therapy may be included if they have a 2-month period without use of cannabis-based therapy prior to enrollment in the study).
* Participants with any level of cannabis in their blood samples when sampled at the commencement of the study will be excluded.
* Participants that are being medically supervised for anxiety, depression, Post Traumatic Stress Disorder (PTSD), mood disorder, psychotic disorders or any cerebrovascular and cardiovascular complications.
* Participants who are taking prescription medications such as psychotropic medications with serotonergic activity, including Selective Serotonin Reuptake Inhibitors (i.e. Fluoxetine), Tricyclic Antidepressants (i.e. Elavil, Nortriptyline) and Atypical Neuroleptics (i.e. Risperidone, Seroquel).
* Initiation or dosage change of oral or injected steroids within 3 months.
* Allergy or known intolerance to any of the compounds within the study preparation.
* Unable to maintain commitment to all proposed biopsychological and health questionnaires, and neuro-physiological, physiological, and functional motor skills laboratory tests.
* Inability of study participants to attend assessments on a regular basis at the pre-determined times, or failure to take the drug daily.
* Clinically significant cardiac, renal or hepatic disease (as assessed by the site investigator).
* If they already have a concussion at the time of starting the study.
Primary outcome measure(s)
Plasma cannabidiol (CBD) metabolite concentration — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in plasma concentrations of cannabidiol (CBD) and CBD metabolites measured from venous blood samples.
Plasma tetrahydrocannabinol (THC) metabolite concentration — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in plasma concentrations of tetrahydrocannabinol (THC) and THC metabolites measured from venous blood samples.
Inflammatory biomarker concentrations in blood — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in blood concentrations of inflammatory and neurobiological biomarkers, including tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), brain-derived neurotrophic factor (BDNF), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP), measured from venous blood samples.
Liver function laboratory values — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in liver function laboratory values, including total protein, albumin, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP), measured from venous blood samples at a provincial accredited laboratory.
Hematology and clinical chemistry laboratory values — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in complete blood count, blood differential, sodium, potassium, chloride, total CO2, calcium, magnesium, phosphate, and creatinine measured from venous blood samples.
Cerebral blood flow velocity — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in cerebral blood flow velocity in the middle cerebral artery and posterior cerebral artery measured by transcranial Doppler ultrasound.
Cerebral oxygenation — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in cerebral oxygenation in the right and left prefrontal cortex measured by functional near-infrared spectroscopy.
Continuous blood pressure — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in continuous blood pressure measured using Finapres Nova finger photoplethysmography.
Changes in cardiovascular physiology — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Change in cardiac cycle timing parameters measured using seismocardiography (SCG).
Officially diagnosed concussion incidence — From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). Number of officially diagnosed concussions sustained by participants during the study period.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.