Clinical trial NCT06204003: Cannabinoids for Pain Management and Neuroprotection From Concussion
Official title: Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports: Dose Escalation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: National Football League (NFL)
name: My Next Health Inc.
First posted: 2024-01-12
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive placebo at Day 0. CBD 5 mg/kg will begin Day 15. CBD 10 mg/kg will begin Day 30. CBD 15 mg/kg will begin Day 45. CBD 20 mg/kg will begin Day 60. CBD 25 mg/kg will begin Day75. CBD 30 mg/kg will begin Day 90.
Primary purpose: TREATMENT

Brief summary: The goal of this open-label, placebo-controlled, dosage escalation study is to learn about the safety of a Cannabis/Hemp Isolate Extract in normal healthy adults engaged in elite contact sport competition.

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.

Detailed description: This research project will be a Phase I clinical trial to test the safety, efficacy and tolerability of the drug formulation. Specifically, the investigators will use a dose escalation study with all participants taking a placebo before starting the CBD regimen. This study is designed to investigate anti-inflammatory and neuroprotection of the CBD formulation to determine whether it can be used on a daily basis safely during the periods of intensive exercise (resistance) training during the off-season prior to competition.

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.

Eligibility criteria: Inclusion Criteria:

* Healthy male adults between 18-35 years of age that compete in contact sport athletics
* 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:

* Female
* 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

Primary outcomes:
measure: Change in cerebrovascular and cardiovascular physiology
timeFrame: Every 15 days from Day 0 to Day 104
measure: Incidence of potential harmful side effects
timeFrame: Every 15 days from Day 0 to Day 104
Secondary outcomes:
measure: Assessment of GABAergic activity
timeFrame: Every 15 days from Day 0 to Day 104
measure: Change in pain intensity
timeFrame: Every 15 days from Day 0 to Day 104
measure: Cerebral blood flow (transcranial Doppler)
timeFrame: Every 15 days from Day 0 to Day 104
measure: Cerebral oxygenation (near infrared spectroscopy)
timeFrame: Every 15 days from Day 0 to Day 104
measure: Change in QoL
timeFrame: up to day 104
measure: Incidence of AEs
timeFrame: Through study completion, From Day 0 to Day 104
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
city: Regina
country: Canada
facility: Pasqua Hospital
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Patrick Neary
role: STUDY_DIRECTOR
affiliation: Saskatchewan Health Authority - Regina Area
name: Payam Dehghani,
role: PRINCIPAL_INVESTIGATOR
References: