Cannabinoids for Pain Management and Neuroprotection From Concussion

Last updated: June 28, 2024
Sponsor: University of Regina
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Cannabis/Hemp Isolate Extract

Clinical Study ID

NCT06204003
3455
NFL-CBD-01
  • Ages 18-35
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male adults between 18-35 years of age that compete in contact sportathletics

  • 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 thestudy

  • Agree to list any prescription medications being taken

  • Ability to maintain commitment to all proposed biopsychological and healthquestionnaires, and neuro-physiological, physiological, perceptual-cognitive, andfunctional motor skills laboratory tests

Exclusion

Exclusion Criteria:

  • Female

  • Requirement to travel to the USA during study period; USA laws do not permit crossborder with cannabis products

  • Use of cannabis-based therapy within 2 months (participants who have previously useda cannabis based therapy may be included if they have a 2 month period without useof 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, orfailure to take drug on a daily basis

  • Clinically significant cardiac, renal or hepatic disease (as assessed by the siteinvestigator)

  • Concussion

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Cannabis/Hemp Isolate Extract
Phase: 1
Study Start date:
February 15, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Pasqua Hospital

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • University of Regina

    Regina, Saskatchewan S4S 0A2
    Canada

    Active - Recruiting

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