A Phase 2 interventional study of Broad spectrum cannabinoid formulation and Placebo gel capsule in Healthy, sponsored by University of Regina. Recruiting at 1 site in Canada. Open to male participants aged 19 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Regina · Phase 2, Interventional, and Treatment
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 :
Participants will:
This research project will be a Phase II clinical trial to test the neuroprotective properties of the broad spectrum cannabinoid formulation. Specifically, the investigators will assess the neuroprotective properties of the cannabinoid formulation during a competitive season of contact football or ice hockey in elite university varsity athletics.
The primary research hypothesis is that the cannabinoid formulation will be neuroprotective for athletes in a competitive university varsity football or hockey season and will help to reduce the number of concussions sustained by the athletes in comparison to previous seasons, and in comparison, to the Placebo group. Furthermore, it is expected that the cannabinoid formulation will facilitate recovery in those who do suffer from a concussion by reducing inflammation.
The secondary hypotheses are:
This research study is unique and important for several reasons:
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 60 is close to the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Regina is the lead sponsor of 58 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gel capsule containing broad spectrum cannabinoid formulation
Drug: Broad spectrum cannabinoid formulation
Placebo gel capsule
Other: Placebo gel capsule
Broad spectrum cannabinoid formulation gel capsule
Placebo gel capsule will have MCT oil only, no active ingredient
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).
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).
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).
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).
Hematology and clinical chemistry laboratory values
Change in complete blood count, blood differential, sodium, potassium, chloride, total CO2, calcium, magnesium, phosphate, and creatinine 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).
Cerebral blood flow velocity
Change in cerebral blood flow velocity in the middle cerebral artery and posterior cerebral artery measured by transcranial Doppler ultrasound.
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Cerebral oxygenation
Change in cerebral oxygenation in the right and left prefrontal cortex measured by functional near-infrared spectroscopy.
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Continuous blood pressure
Change in continuous blood pressure measured using Finapres Nova finger photoplethysmography.
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Changes in cardiovascular physiology
Change in cardiac cycle timing parameters measured using seismocardiography (SCG).
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Officially diagnosed concussion incidence
Number of officially diagnosed concussions sustained by participants during the study period.
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
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).
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).
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).
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).
Numeric Rating Scale for Pain score
Change in pain intensity measured using the Numeric Rating Scale (NRS). Participants rate their pain on an 11-point scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. 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.
Pain Behaviour Measurement score
Change in observed pain behavior measured using the Pain Behaviour Measurement (PBM) system. The PBM quantifies the frequency and/or duration of observed pain-related behaviors during standardized assessment. Higher scores indicate greater pain-related behavior. Units: PBM score
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score
The LSEQ is a validated 10-item questionnaire that assesses getting to sleep, quality of sleep, awakening from sleep, and behaviour following wakefulness. Scores are reported on a 0 to 100 visual analogue scale, with higher scores indicating better perceived sleep quality and sleep-related functioning. Units: 0-100 scale score
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Vertical Jump Performance
Change in vertical jump height measured using the Vertec vertical jump test.
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Adverse Event Incidence
Number of participants experiencing adverse events, including sleepiness, lethargy, irritability, nausea, vomiting, and diarrhea.
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Stool microbiome composition
Change in gastrointestinal microbiome composition assessed using stool sample analysis performed using standard laboratory methods.
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Identification of genetic markers associated with cannabinoid metabolism
Single nucleotide polymorphisms and copy number variants associated with inter-individual metabolic differences in cannabinoid metabolism identified using next-generation sequencing.
Time frame: Baseline assessment.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Mar 2027, 9 months after the start.
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University of Regina