Broad-spectrum cannabinoids for neuroprotection in healthy athletes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, double-blind, placebo-controlled, cross-over trial evaluates a broad-spectrum cannabinoid formulation in healthy male adults aged 19-35 who compete in contact sports. Participants receive either the cannabinoid gel capsule or placebo twice daily during a competitive season, with blood and stool samples collected to study pharmacokinetics, inflammation, and gut microbiome, along with safety labs and health assessments. The trial aims to determine if the formulation reduces concussion incidence or improves recovery by lowering inflammation, and whether it enhances physiological and psychological performance compared with placebo. This study is conducted in elite university varsity athletes under an academic sponsor with NFL collaboration and seeks to establish neuroprotective potential in a high-risk population.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Regina
  Regina, Saskatchewan, Canada Recruiting

Study contacts

• Study coordinator: Patrick Neary, Ph.D
• Email: Patrick.Neary@uregina.ca
• Phone: 306-585-4844

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.