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Cannabinoid
THC + CBD for Chronic Kidney Disease (POT-GFR-PK Trial)
Phase 1
Recruiting
Led By Michael Walsh, MD, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult age > 25 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
POT-GFR-PK Trial Summary
This trial tests the effects of THC and CBD on healthy adults and those with chronic kidney disease, including those on dialysis.
Who is the study for?
This trial is for adults over 25 with chronic kidney disease, including those on hemodialysis. Participants must have a body mass index between 20 and 35, no drug dependence (except caffeine or nicotine), no recent cannabis use, and not be taking certain medications that interact with THC/CBD.Check my eligibility
What is being tested?
The study tests how single doses of oral tetrahydrocannabinol (THC) and cannabidiol (CBD) are processed by the body in healthy individuals compared to those with chronic kidney disease, including patients undergoing regular hemodialysis treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with THC/CBD such as changes in mood or perception, dizziness, dry mouth, altered mental state or intoxication. Specific risks for people with kidney conditions could vary.
POT-GFR-PK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are older than 25 years old.
POT-GFR-PK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cannabidiol and its metabolites area under the curve
Cannabidiol and its metabolites dialytic clearance
Cannabidiol and its metabolites last detection time
+15 moreSecondary outcome measures
Adverse events
Blood pressure
Heart rate
POT-GFR-PK Trial Design
1Treatment groups
Experimental Treatment
Group I: THC/CBDExperimental Treatment1 Intervention
Oral THC 0.1mg/kg and CBD 2.5mg/kg
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,866 Total Patients Enrolled
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
605 Total Patients Enrolled
Michael Walsh, MD, PhDPrincipal InvestigatorMcMaster University
2 Previous Clinical Trials
2,950 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious bad reaction to using cannabis.You have a history of serious mental health issues like psychosis or mania.You have used any form of marijuana or synthetic cannabinoids in the last 30 days.You are taking medication that can interact with THC or CBD.Your liver is not working properly, as shown by specific blood test results.You have significantly changed your weight in the last 4 weeks.You experienced low blood pressure during dialysis that needed treatment in the last 4 weeks.Your body mass index is below 20 or above 35.You are addicted to any drug except for caffeine or nicotine.You are older than 25 years old.Your kidney function, measured by eGFR, should be within a certain range. If you are on hemodialysis, it should be through a tunnelled catheter for at least 3 hours per session, at least 2 times per week for more than 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: THC/CBD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the use of THC/CBD officially backed by regulatory approval?
"Our in-house team has rated the safety of THC/CBD to be a 1, signifying limited evidence for both efficacy and security."
Answered by AI
Are any slots for enrollment in this research still available?
"As per clinicaltrials.gov, this medical experiment is now recruiting volunteers. The study was first posted on January 11th 2023 and modified most recently on February 14th of the same year."
Answered by AI
To what extent is this experiment being utilized by participants?
"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting individuals who meet the criteria of participation. The study was initially posted on November 1st 2023 and has since been edited on February 14th 2023; 24 volunteers are required across a single site."
Answered by AI
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