MedTrace Logo

Naturally Produced Cannabinoids for Neuroprotection From Concussion

NCT07715864 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Football League

    collaborator OTHER

  • University of Regina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715864 on ClinicalTrials.gov