Recruiting
Phase 2

Broad-Spectrum Cannabinoid

Sponsor:

University of Regina

Code:

NCT07715864

Conditions

Healthy

Eligibility Criteria

Sex: Male

Age: 19 - 35

Healthy Volunteers: Accepted

Interventions

Broad spectrum cannabinoid formulation

Placebo gel capsule

Study Details

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

Study ID

NCT07715864

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 19 - 35

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Broad sprectrum cannabinoid gel capsule

Gel capsule containing broad spectrum cannabinoid formulation

placebo comparator: Placebo

Placebo gel capsule

Interventions

Broad spectrum cannabinoid formulation

Broad spectrum cannabinoid formulation gel capsule

Placebo gel capsule

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

Primary outcome measure

  • Plasma cannabidiol (CBD) metabolite concentration [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Plasma tetrahydrocannabinol (THC) metabolite concentration [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Inflammatory biomarker concentrations in blood [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Liver function laboratory values [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Hematology and clinical chemistry laboratory values [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Cerebral blood flow velocity [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Cerebral oxygenation [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Continuous blood pressure [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Changes in cardiovascular physiology [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]
  • Officially diagnosed concussion incidence [ Time Frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants). ]

Central Contacts and Locations

Central contacts

Patrick Neary, Ph.D

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

Elizabeth S. Thompson, Ph.D

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

Locations

University of Regina

Recruiting

Regina, Saskatchewan, Canada, S4S-0A2

Contacts

Patrick Neary, Ph.D

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

More Information

Sponsor

University of Regina

Last update posted

Jul 21, 2026

Last verified

Jun, 2026

Keywords

  • cannabis
  • hemp
  • cannabinoid
  • concussion
  • inflammation
  • cbd

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2026-07-21.