Naturally Produced Cannabinoids for Neuroprotection From Concussion
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age19-35
SponsorUniversity of Regina
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Broad spectrum cannabinoid formulation
- Placebo gel capsule
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Regina
Lead sponsor
National Football League
Collaborator
Source ClinicalTrials.gov