Cannabinoids for Pain Management and Neuroprotection From Concussion

Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports: Dose Escalation

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Cannabis/Hemp Isolate Extract

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Patrick Neary; Phone Number: 306-585-4844; Email: Patrick.neary@uregina.ca
• Study Contact Backup: Name: Jyotpal Singh; Email: singh32j@gmail.com

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 0A2
      • Recruiting
      • University of Regina
      • Contact: Patrick Neary
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Not yet recruiting
      • Pasqua Hospital
      • Contact: Patrick Neary; Phone Number: 306-585-4844; Email: Patrick.neary@uregina.ca
      • Contact: Payam Dehghani; Phone Number: 306-766-6237; Email: payam.dehghani@saskhealthauthority.ca
      • Principal Investigator: Payam Dehghani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Cannabis/Hemp Isolate Extract; Formulation: CBD (99%; 0.1% THC isolate); Other Names: Herbal Extract with a high CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cerebrovascular and cardiovascular physiology	Monitor the participant's cerebrovascular and cardiovascular physiology before and after the dosage regimen	Every 15 days from Day 0 to Day 104
Incidence of potential harmful side effects	Follow the participants enrolled in these studies at set intervals to monitor for potential harmful side effects of the high CBD cannabis/hemp extract. This will include bloodwork to assess for possible hematopoietic, renal or hepatic dysfunction, and pharmacokinetic and pharmacodynamic analysis of the dose escalation protocol	Every 15 days from Day 0 to Day 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of GABAergic activity	Assess the inhibitory neurotransmitter δ-aminobutyric acid (GABAergic activity)	Every 15 days from Day 0 to Day 104
Change in pain intensity	Pain Behaviour Measurement system (PBM) scale	Every 15 days from Day 0 to Day 104
Cerebral blood flow (transcranial Doppler)	Assessment of cerebral hemodynamic activity	Every 15 days from Day 0 to Day 104
Cerebral oxygenation (near infrared spectroscopy)	Assessment of cerebral hemodynamic activity	Every 15 days from Day 0 to Day 104
Change in QoL	Assess quality of life (QOL) in study participants by scores on health questionnaires and medication use	up to day 104
Incidence of AEs	Assess adverse events (AEs) in study participants by looking at sleepiness/lethargy, irritability, nausea/vomiting and diarrhea	Through study completion, From Day 0 to Day 104

Collaborators and Investigators

• Sponsor: University of Regina
• Collaborators: National Football League (NFL); My Next Health Inc.
• Investigators: Study Director: Patrick Neary, University of Regina; Principal Investigator: Payam Dehghani,, Saskatchewan Health Authority - Regina Area

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 3455 (University of Pittsburgh Pitt Momentum Fund); NFL-CBD-01 (Other Identifier: URegina)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No