Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204003
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-07-24
Brief Title:
Cannabinoids for Pain Management and Neuroprotection From Concussion
Sponsor:
University of Regina
Organization:
University of Regina
Study Overview
Official Title:
Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports Dose Escalation
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this open-label placebo-controlled dosage escalation study is to learn about the safety of a CannabisHemp Isolate Extract in normal healthy adults engaged in elite contact sport competition
The main question it aims to answer is
Are cannabishemp-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 CBDkg body mass which will be increased by 5 mgkg every 2-weeks until 30 mg CBDkg 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
The main question it aims to answer is
Are cannabishemp-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 CBDkg body mass which will be increased by 5 mgkg every 2-weeks until 30 mg CBDkg 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 cannabishemp-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 andor its active metabolites will correlate with cerebrovascular neurophysiology and cardiovascular physiology outcome variables
3 Saliva levels of CBD andor its active metabolites will correlate with plasma samples
The primary research hypothesis is that cannabishemp-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 andor its active metabolites will correlate with cerebrovascular neurophysiology and cardiovascular physiology outcome variables
3 Saliva levels of CBD andor its active metabolites will correlate with plasma samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NFL-CBD-01 | OTHER | URegina | None |