Cannabinoids for Pain Management and Neuroprotection From Concussion
NCT ID: NCT06204003
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
35 participants
INTERVENTIONAL
2024-02-15
2026-12-31
Brief Summary
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The main question it aims to answer is:
• Are cannabis/hemp-based products with high CBD safe, well-tolerated and without adverse physiological and psychological dysfunction, when administered on a daily basis?
Participants will:
* be given CBD and a placebo. The placebo will be taken for 2 weeks prior to starting the CBD. Participants will start on a low dose of CBD, beginning at 5 mg CBD/kg body mass, which will be increased by 5 mg/kg every 2-weeks until 30 mg CBD/kg body mass is taken;
* have blood samples taken to analyse how much CBD is used in the body and for how long it lasts in the body (pharmacokinetics and pharmacodynamics);
* have saliva samples collected for genetic analysis;
* undergo testing sessions, which will include psychological and health questionnaires, equipment to record signals from the brain and heart, and safety laboratory tests.
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Detailed Description
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The primary research hypothesis is that cannabis/hemp-based products with high CBD are safe, well-tolerated and do not cause adverse physiological and psychological dysfunction when administered on a daily basis. Specifically, the investigators will investigate the pharmacokinetic, physiological, and psychological effects of CBD. The investigators hypothesize that the CBD formulations will be non-intoxicating (non-psychotropic), safe, well-tolerated and do not cause adverse physiological or psychological dysfunction.
Secondary research hypotheses for this clinical trial:
1. Pharmacokinetic data will provide the investigators with the 'optimal' formulation for daily administration for neuroprotection from concussion
2. Plasma levels of CBD and/or its active metabolites will correlate with cerebrovascular, neurophysiology and cardiovascular physiology outcome variables.
3. Saliva levels of CBD and/or its active metabolites will correlate with plasma samples.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation
When participants start the CBD, they will be started on a low dose of CBD, beginning at 5 mg CBD/kg body mass, and then increased by 5 mg/kg every 2-weeks until 30 mg CBD/kg body mass is taken.
Cannabis/Hemp Isolate Extract
Formulation: CBD (99%; 0.1% THC isolate)
Interventions
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Cannabis/Hemp Isolate Extract
Formulation: CBD (99%; 0.1% THC isolate)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No known cerebrovascular or cardiovascular complications
* Not habitual recreational users of cannabis (i.e., \<1 day/week) or tobacco users
* Agree not to consume any other cannabis or tobacco products while enrolled in the study
* Agree to list any prescription medications being taken
* Ability to maintain commitment to all proposed biopsychological and health questionnaires, and neuro-physiological, physiological, perceptual-cognitive, and functional motor skills laboratory tests
Exclusion Criteria
* Requirement to 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 enrolment in the study)
* Any level of cannabis in blood samples when sampled at the commencement of the study
* Medically supervised for anxiety, depression, or other neurological conditions
* Initiation or dosage change of oral or injected steroids within past 3 months
* Allergy or known intolerance to any of the compounds within the study preparation
* Inability to attend assessments on a regular basis at the pre-determined times, or failure to take drug on a daily basis
* Clinically significant cardiac, renal or hepatic disease (as assessed by the site investigator)
* Concussion
18 Years
35 Years
MALE
Yes
Sponsors
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National Football League (NFL)
UNKNOWN
My Next Health Inc.
UNKNOWN
University of Regina
OTHER
Responsible Party
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Principal Investigators
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Patrick Neary
Role: STUDY_DIRECTOR
University of Regina
Payam Dehghani,
Role: PRINCIPAL_INVESTIGATOR
Saskatchewan Health Authority - Regina Area
Locations
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University of Regina
Regina, Saskatchewan, Canada
Pasqua Hospital
Regina, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Patrick Neary
Role: primary
References
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Neary JP, Singh J, Alcorn J, Laprairie RB, Dehghani P, Mang CS, Bjornson BH, Hadjistavropoulos T, Bardutz HA, Bhagaloo L, Walsh Z, Szafron M, Dorsch KD, Thompson ES. Pharmacological and physiological effects of cannabidiol: a dose escalation, placebo washout study protocol. BMC Neurol. 2024 Sep 12;24(1):340. doi: 10.1186/s12883-024-03847-1.
Other Identifiers
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NFL-CBD-01
Identifier Type: OTHER
Identifier Source: secondary_id
3455
Identifier Type: -
Identifier Source: org_study_id
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