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RECRUITING

NCT07715864

PHASE2

Naturally Produced Cannabinoids for Neuroprotection From Concussion

Sponsor: University of Regina

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

19 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-01

Completion Date

2027-03

Last Updated

2026-07-21

Healthy Volunteers

Yes

Conditions

Healthy

Interventions

DRUG

Broad spectrum cannabinoid formulation

Broad spectrum cannabinoid formulation gel capsule

OTHER

Placebo gel capsule

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

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.

Locations (1)

University of Regina

Regina, Saskatchewan, Canada