HealthyPhase 2NCT07715864
Naturally Produced Cannabinoids for Neuroprotection From Concussion
A Phase 2 study testing Broad spectrum cannabinoid formulation in people with Healthy, run by University of Regina at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Broad spectrum cannabinoid formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan, S4S-0A2
Patrick Neary, Ph.D, 306-585-4844, Patrick.Neary@uregina.ca
About this study
Official title: Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports: Neuroprotection
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 :
Read more
- 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.
Read the detailed description
This research project will be a Phase II clinical trial to test the neuroprotective properties of the broad spectrum cannabinoid formulation. Specifically, the investigators will assess the neuroprotective properties of the cannabinoid formulation during a competitive season of contact football or ice hockey in elite university varsity athletics.
The primary research hypothesis is that the cannabinoid formulation will be neuroprotective for athletes in a competitive university varsity football or hockey season and will help to reduce the number of concussions sustained by the athletes in comparison to previous seasons, and in comparison, to the Placebo group. Furthermore, it is expected that the cannabinoid formulation will facilitate recovery in those who do suffer from a concussion by reducing inflammation.
The secondary hypotheses are:
- The cannabinoid formulation will result in improved physiological and psychological performance throughout the competitive season compared to placebo.
- The inflammatory markers will be reduced in those taking the cannabinoid formulation as compared to those taking placebo.
This research study is unique and important for several reasons:
- The investigators will conduct the first ever randomized controlled trial to understand the neuroprotective effects of a cannabinoid formulation designed to mitigate concussion in a population at a heightened risk of concussion and understand if recovery with the cannabinoid formulation more rapidly improves concussion symptoms.
- The investigators will use an integrated approach to examine the effects of our cannabinoid formulation on qualitative and quantitative outcome measures including clinical, physiological, neurophysiological, biopsychological, and functional motor performance.
- The cannabinoid levels will be studied in the blood to assess the pharmacokinetics and pharmacodynamics of these compounds and correlate these with our cerebrovascular, cardiovascular and neurophysiological indices.
- The investigators will genotype participant blood samples for known polymorphisms (single nucleotide polymorphisms, copy number variants, etc.) and relate our findings to observed drug effect in study participants.
- The investigators will investigate the effects of the cannabinoid formulation on the gut microbiome from stool samples, which has been implicated to have an effect on concussion.
- Conditions
- Healthy
- Being tested
- Broad spectrum cannabinoid formulation, Placebo gel capsule
- Keywords
- cannabis, hemp, cannabinoid, concussion, inflammation, cbd
- Medical subject headings
- Marijuana Abuse, Brain Concussion, Inflammation, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad spectrum cannabinoid formulationDrug
Broad spectrum cannabinoid formulation gel capsule
Placebo gel capsuleOther
Placebo gel capsule will have MCT oil only, no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Broad sprectrum cannabinoid gel capsule | Experimental | Gel capsule containing broad spectrum cannabinoid formulation Receives: Drug: Broad spectrum cannabinoid formulation |
| Placebo | Placebo comparator | Placebo gel capsule Receives: Other: Placebo gel capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma cannabidiol (CBD) metabolite concentration
Change in plasma concentrations of cannabidiol (CBD) and CBD metabolites measured from venous blood samples.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Plasma tetrahydrocannabinol (THC) metabolite concentration
Change in plasma concentrations of tetrahydrocannabinol (THC) and THC metabolites measured from venous blood samples.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Inflammatory biomarker concentrations in blood
Change in blood concentrations of inflammatory and neurobiological biomarkers, including tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), brain-derived neurotrophic factor (BDNF), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP), measured from venous blood samples.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Liver function laboratory values
Change in liver function laboratory values, including total protein, albumin, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP), measured from venous blood samples at a provincial accredited laboratory.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Hematology and clinical chemistry laboratory values
Change in complete blood count, blood differential, sodium, potassium, chloride, total CO2, calcium, magnesium, phosphate, and creatinine measured from venous blood samples.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Cerebral blood flow velocity
Change in cerebral blood flow velocity in the middle cerebral artery and posterior cerebral artery measured by transcranial Doppler ultrasound.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Cerebral oxygenation
Change in cerebral oxygenation in the right and left prefrontal cortex measured by functional near-infrared spectroscopy.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Continuous blood pressure
Change in continuous blood pressure measured using Finapres Nova finger photoplethysmography.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Changes in cardiovascular physiology
Change in cardiac cycle timing parameters measured using seismocardiography (SCG).
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Officially diagnosed concussion incidence
Number of officially diagnosed concussions sustained by participants during the study period.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Secondary outcomes (11)
Cortical inhibition measured by transcranial magnetic stimulation (TMS)
Monitor excitatory:inhibitory ratio of neurotransmitter activity via transcranial magnetic stimulation (TMS) including cortical silent period and short-interval intracortical inhibition.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Brief Pain Inventory-Short Form Pain Interference score
Change in pain interference measured using the Brief Pain Inventory-Short Form (BPI-SF) Pain Interference Scale. The Pain Interference score is calculated as the mean of seven items assessing interference with general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life. Scores range from 0 to 10, with higher scores indicating greater pain interference.
Units: 0-10 scale score
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Brief Pain Inventory-Short Form Pain Severity Score
Change in pain severity measured using the Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Scale. The Pain Severity score is calculated as the mean of four items (worst, least, average, and current pain). Scores range from 0 to 10, with higher scores indicating greater pain severity.
Units: 0-10 scale score
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
McGill Pain Questionnaire-Short Form pain score
Change in pain measured using the Short-Form McGill Pain Questionnaire (SF-MPQ). The questionnaire includes 15 pain descriptors (11 sensory and 4 affective), each rated from 0 (none) to 3 (severe). The total score ranges from 0 to 45, with higher scores indicating greater pain severity.
Units: 0-45 scale score
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Numeric Rating Scale for Pain score
Change in pain intensity measured using the Numeric Rating Scale (NRS). Participants rate their pain on an 11-point scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Units: 0-10 scale score
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants.
Pain Behaviour Measurement score
Change in observed pain behavior measured using the Pain Behaviour Measurement (PBM) system. The PBM quantifies the frequency and/or duration of observed pain-related behaviors during standardized assessment. Higher scores indicate greater pain-related behavior.
Units: PBM score
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score
The LSEQ is a validated 10-item questionnaire that assesses getting to sleep, quality of sleep, awakening from sleep, and behaviour following wakefulness. Scores are reported on a 0 to 100 visual analogue scale, with higher scores indicating better perceived sleep quality and sleep-related functioning.
Units: 0-100 scale score
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Vertical Jump Performance
Change in vertical jump height measured using the Vertec vertical jump test.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Adverse Event Incidence
Number of participants experiencing adverse events, including sleepiness, lethargy, irritability, nausea, vomiting, and diarrhea.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Stool microbiome composition
Change in gastrointestinal microbiome composition assessed using stool sample analysis performed using standard laboratory methods.
Measured: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Identification of genetic markers associated with cannabinoid metabolism
Single nucleotide polymorphisms and copy number variants associated with inter-individual metabolic differences in cannabinoid metabolism identified using next-generation sequencing.
Measured: Baseline assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind, placebo controlled, cross over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- National Football League
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715864
- Sponsor's protocol ID
- Bio3456
- Other IDs
- NFL-NEUROPROTECTION-02
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports: Neuroprotection
- ClinicalTrials.gov ID
- NCT07715864
- Acronym / sponsor ID
- Bio3456
- Conditions
- Healthy
- Keywords
- cannabis, hemp, cannabinoid, concussion, inflammation, cbd
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- National Football League
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research project will be a Phase II clinical trial to test the neuroprotective properties of the broad spectrum cannabinoid formulation. Specifically, the investigators will assess the neuroprotective properties of the cannabinoid formulation during a competitive season of contact football or ice hockey in elite university varsity athletics.
The primary research hypothesis is that the cannabinoid formulation will be neuroprotective for athletes in a competitive university varsity football or hockey season and will help to reduce the number of concussions sustained by the athletes in comparison to previous seasons, and in comparison, to the Placebo group. Furthermore, it is expected that the cannabinoid formulation will facilitate recovery in those who do suffer from a concussion by reducing inflammation.
The secondary hypotheses are:
- The cannabinoid formulation will result in improved physiological and psychological performance throughout the competitive season compared to placebo.
- The inflammatory markers will be reduced in those taking the cannabinoid formulation as compared to those taking placebo.
This research study is unique and important for several reasons:
- The investigators will conduct the first ever randomized controlled trial to understand the neuroprotective effects of a cannabinoid formulation designed to mitigate concussion in a population at a heightened risk of concussion and understand if recovery with the cannabinoid formulation more rapidly improves concussion symptoms.
- The investigators will use an integrated approach to examine the effects of our cannabinoid formulation on qualitative and quantitative outcome measures including clinical, physiological, neurophysiological, biopsychological, and functional motor performance.
- The cannabinoid levels will be studied in the blood to assess the pharmacokinetics and pharmacodynamics of these compounds and correlate these with our cerebrovascular, cardiovascular and neurophysiological indices.
- The investigators will genotype participant blood samples for known polymorphisms (single nucleotide polymorphisms, copy number variants, etc.) and relate our findings to observed drug effect in study participants.
- The investigators will investigate the effects of the cannabinoid formulation on the gut microbiome from stool samples, which has been implicated to have an effect on concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, placebo controlled, cross over study
| Arm | Type | Receives |
|---|---|---|
| Broad sprectrum cannabinoid gel capsule | Experimental | Drug: Broad spectrum cannabinoid formulationGel capsule containing broad spectrum cannabinoid formulation |
| Placebo | Placebo comparator | Other: Placebo gel capsulePlacebo gel capsule |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad spectrum cannabinoid formulationBroad spectrum cannabinoid formulation gel capsule | Drug | Broad sprectrum cannabinoid gel capsule |
| Placebo gel capsulePlacebo gel capsule will have MCT oil only, no active ingredient | Other | Placebo |
Primary outcome
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).
Change in plasma concentrations of cannabidiol (CBD) and CBD metabolites measured from venous blood samples.
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).
Change in plasma concentrations of tetrahydrocannabinol (THC) and THC metabolites measured from venous blood samples.
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).
Change in blood concentrations of inflammatory and neurobiological biomarkers, including tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), brain-derived neurotrophic factor (BDNF), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP), measured from venous blood samples.
Liver function laboratory values
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in liver function laboratory values, including total protein, albumin, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP), measured from venous blood samples at a provincial accredited laboratory.
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).
Change in complete blood count, blood differential, sodium, potassium, chloride, total CO2, calcium, magnesium, phosphate, and creatinine measured from venous blood samples.
Cerebral blood flow velocity
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in cerebral blood flow velocity in the middle cerebral artery and posterior cerebral artery measured by transcranial Doppler ultrasound.
Cerebral oxygenation
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in cerebral oxygenation in the right and left prefrontal cortex measured by functional near-infrared spectroscopy.
Continuous blood pressure
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in continuous blood pressure measured using Finapres Nova finger photoplethysmography.
Changes in cardiovascular physiology
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in cardiac cycle timing parameters measured using seismocardiography (SCG).
Officially diagnosed concussion incidence
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Number of officially diagnosed concussions sustained by participants during the study period.
11 secondary outcomes
Cortical inhibition measured by transcranial magnetic stimulation (TMS)
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Brief Pain Inventory-Short Form Pain Interference score
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Brief Pain Inventory-Short Form Pain Severity Score
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
McGill Pain Questionnaire-Short Form pain score
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Numeric Rating Scale for Pain score
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants.
Pain Behaviour Measurement score
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Vertical Jump Performance
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Adverse Event Incidence
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Stool microbiome composition
Time frame: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Identification of genetic markers associated with cannabinoid metabolism
Time frame: Baseline assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Broad spectrum cannabinoid formulation in people with Healthy, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Neary, Ph.D (306-585-4844, Patrick.Neary@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.