MedTrace Logo

Cannabinoids for Pain Management and Neuroprotection From Concussion

NCT06204003 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-05-06

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Cannabis/Hemp Isolate Extract

Formulation: CBD (99%; 0.1% THC isolate)

Sponsors & Collaborators

  • National Football League (NFL)

    collaborator UNKNOWN

  • My Next Health Inc.

    collaborator UNKNOWN

  • University of Regina

    lead OTHER

Principal Investigators

  • Patrick Neary · University of Regina

  • Payam Dehghani, · Saskatchewan Health Authority - Regina Area

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204003 on ClinicalTrials.gov