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Naturally Produced Cannabinoids for Neuroprotection From Concussion

14. juli 2026 opdateret af: University of Regina

Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports: Neuroprotection

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  1. The cannabinoid formulation will result in improved physiological and psychological performance throughout the competitive season compared to placebo.
  2. The inflammatory markers will be reduced in those taking the cannabinoid formulation as compared to those taking placebo.

This research study is unique and important for several reasons:

  1. The investigators will conduct the first ever randomized controlled trial to understand the neuroprotective effects of a cannabinoid formulation designed to mitigate concussion in a population at a heightened risk of concussion and understand if recovery with the cannabinoid formulation more rapidly improves concussion symptoms.
  2. The investigators will use an integrated approach to examine the effects of our cannabinoid formulation on qualitative and quantitative outcome measures including clinical, physiological, neurophysiological, biopsychological, and functional motor performance.
  3. The cannabinoid levels will be studied in the blood to assess the pharmacokinetics and pharmacodynamics of these compounds and correlate these with our cerebrovascular, cardiovascular and neurophysiological indices.
  4. The investigators will genotype participant blood samples for known polymorphisms (single nucleotide polymorphisms, copy number variants, etc.) and relate our findings to observed drug effect in study participants.
  5. The investigators will investigate the effects of the cannabinoid formulation on the gut microbiome from stool samples, which has been implicated to have an effect on concussion.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S-0A2
        • Rekruttering
        • University of Regina
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Broad sprectrum cannabinoid gel capsule
Gel capsule containing broad spectrum cannabinoid formulation
Medicin: Broad spectrum cannabinoid formulation
Broad spectrum cannabinoid formulation gel capsule
Placebo komparator: Placebo
Placebo gel capsule
Andet: Placebo gel capsule
Placebo gel capsule will have MCT oil only, no active ingredient

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma cannabidiol (CBD) metabolite concentration
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Plasma tetrahydrocannabinol (THC) metabolite concentration
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Inflammatory biomarker concentrations in blood
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Liver function laboratory values
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Hematology and clinical chemistry laboratory values
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Cerebral blood flow velocity
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Cerebral oxygenation
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Continuous blood pressure
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Changes in cardiovascular physiology
Tidsramme: 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).
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Officially diagnosed concussion incidence
Tidsramme: 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.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cortical inhibition measured by transcranial magnetic stimulation (TMS)
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Monitor excitatory:inhibitory ratio of neurotransmitter activity via transcranial magnetic stimulation (TMS) including cortical silent period and short-interval intracortical inhibition.
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
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).

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
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
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).

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
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
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).

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
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Numeric Rating Scale for Pain score
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants.

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
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants.
Pain Behaviour Measurement score
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).

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
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
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).

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
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Vertical Jump Performance
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in vertical jump height measured using the Vertec vertical jump test.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Adverse Event Incidence
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Number of participants experiencing adverse events, including sleepiness, lethargy, irritability, nausea, vomiting, and diarrhea.
From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Stool microbiome composition
Tidsramme: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in gastrointestinal microbiome composition assessed using stool sample analysis performed using standard laboratory methods.
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
Tidsramme: Baseline assessment.
Single nucleotide polymorphisms and copy number variants associated with inter-individual metabolic differences in cannabinoid metabolism identified using next-generation sequencing.
Baseline assessment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Regina

Samarbejdspartnere

National Football League

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Bio3456
  • NFL-NEUROPROTECTION-02 (Anden identifikator: University of Regina)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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