Naturally Produced Cannabinoids for Neuroprotection From Concussion

NCT07715864 | Recruiting Phase 2

• 2 other identifiers: Bio3456NFL-NEUROPROTECTION-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

cannabis; hemp; cannabinoid; concussion; inflammation; cbd

Outcome Measures

Primary Outcomes (10)

• Plasma cannabidiol (CBD) metabolite concentration

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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).

Secondary Outcomes (11)

• Cortical inhibition measured by transcranial magnetic stimulation (TMS)

  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

  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

  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

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

• Numeric Rating Scale for Pain score

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

Study Arms (2)

Broad sprectrum cannabinoid gel capsule

EXPERIMENTAL

Gel capsule containing broad spectrum cannabinoid formulation

Drug: Broad spectrum cannabinoid formulation

Placebo

PLACEBO COMPARATOR

Placebo gel capsule

Other: Placebo gel capsule

Interventions

Broad spectrum cannabinoid formulation DRUG

Broad spectrum cannabinoid formulation gel capsule

Broad sprectrum cannabinoid gel capsule

Placebo gel capsule OTHER

Placebo gel capsule will have MCT oil only, no active ingredient

Placebo

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Regina: lead
• National Football League: collaborator

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S-0A2, Canada

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse; Brain Concussion; Inflammation; Color Vision Defects

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms

Central Study Contacts

Patrick Neary, Ph.D

CONTACT

306-585-4844; Patrick.Neary@uregina.ca

Elizabeth S. Thompson, Ph.D

CONTACT

708-774-7698; e.thompson@usask.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, placebo controlled, cross over study

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 21, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)