THC + CBD for Chronic Kidney Disease

(POT-GFR-PK Trial)

Overseen By David Collister, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: McMaster University

Must not be taking: Anti-epileptic, Calcineurin inhibitors, Anti-fungal

Disqualifiers: Psychosis, Mania, Liver dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 48

Duration: 48 hours

24 Participants Needed

Trial Summary

What is the purpose of this trial?

POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.

Research Team

Michael Walsh, MD, PhD

Principal Investigator

McMaster University

Eligibility Criteria

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.

Inclusion Criteria

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.

Agree to take the medication as directed in the study

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of oral THC and CBD, followed by blood, urine, and dialysate sample collection

48 hours

Multiple visits for sample collection within 48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and vital signs

48 hours

Treatment Details

Interventions

• Tetrahydrocannabinol-Cannabidiol Combination

Trial Overview 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.

Participant Groups

Group I: THC/CBD Experimental Treatment 1 Intervention

Oral THC 0.1mg/kg and CBD 2.5mg/kg

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Center for Medicinal Cannabis Research

Collaborator

Trials

19

Recruited

630+