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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cannabidiol and its metabolites area under the curve
Cannabidiol and its metabolites dialytic clearance
Cannabidiol and its metabolites last detection time
+15 moreSecondary study objectives
Adverse events
Blood pressure
Heart rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: THC/CBDExperimental Treatment1 Intervention
Oral THC 0.1mg/kg and CBD 2.5mg/kg
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,204 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
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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.
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