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Official title Naturally Produced Cannabinoids for Neuroprotection From Concussion
ClinicalTrials.gov ID: NCT07715864
What this study is testing
What is Broad spectrum cannabinoid formulation?
Broad spectrum cannabinoid formulation is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 35, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Participants who are taking prescription medications such as psychotropic medications with serotonergic activity, including Selective Serotonin...
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Regina, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 19 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Regina, Saskatchewan, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.