Naturally Produced Cannabinoids for Neuroprotection From Concussion
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age19-35
SponsorUniversity of Regina
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Broad spectrum cannabinoid formulation
DrugBroad spectrum cannabinoid formulation gel capsule
Placebo gel capsule
Other interventionPlacebo gel capsule will have MCT oil only, no active ingredient
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Broad sprectrum cannabinoid gel capsuleExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Plasma cannabidiol (CBD) metabolite concentration
Change in plasma concentrations of cannabidiol (CBD) and CBD metabolites measured from venous blood samples.
Time frame
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).2
Plasma tetrahydrocannabinol (THC) metabolite concentration
Change in plasma concentrations of tetrahydrocannabinol (THC) and THC metabolites measured from venous blood samples.
Time frame
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).3
Inflammatory biomarker concentrations in blood
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.
Time frame
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).4
Liver function laboratory values
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.
Time frame
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).Secondary outcomes
1
Cortical inhibition measured by transcranial magnetic stimulation (TMS)
Monitor excitatory:inhibitory ratio of neurotransmitter activity via transcranial magnetic stimulation (TMS) including cortical silent period and short-interval intracortical inhibition.
Time frame
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).2
Brief Pain Inventory-Short Form Pain Interference score
Change in pain interference measured using the Brief Pain Inventory-Short Form (BPI-SF) Pain Interference Scale. The Pain Interference score is calculated as the mean of seven items assessing interference with general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life. Scores range from 0 to 10, with higher scores indicating greater pain interference. Units: 0-10 scale score
Time frame
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).3
Brief Pain Inventory-Short Form Pain Severity Score
Change in pain severity measured using the Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Scale. The Pain Severity score is calculated as the mean of four items (worst, least, average, and current pain). Scores range from 0 to 10, with higher scores indicating greater pain severity. Units: 0-10 scale score
Time frame
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).4
McGill Pain Questionnaire-Short Form pain score
Change in pain measured using the Short-Form McGill Pain Questionnaire (SF-MPQ). The questionnaire includes 15 pain descriptors (11 sensory and 4 affective), each rated from 0 (none) to 3 (severe). The total score ranges from 0 to 45, with higher scores indicating greater pain severity. Units: 0-45 scale score
Time frame
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Regina
Lead sponsor
National Football League
Collaborator
Source ClinicalTrials.gov