Active — Not RecruitingPhase 1

The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol

Canada24 participantsStarted 2024-01-11

Plain-language summary

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.

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. adult age\>25 years
. estimated glomerular filtration rate (eGFR)\>60ml/min/1.73m2 or eGFR\<60ml/min/1.73m2 by the CKD Epidemiology Collaboration equation including in-center hemodialysis at least 2x weekly for a minimum of 3 hours per treatment via a tunnelled catheter treated \>90 days
. agree to take the medication as directed in the study
. provides informed consent

Exclusion criteria

. body mass index \<20 or \>35kg/m2
. physical dependence on any drug other than caffeine or nicotine
. history of clinically significant adverse event associated with cannabis intoxication
. history of psychosis or mania or any active major psychiatric disorder
. recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids
. taking any medication with known interactions with THC or CBD via cytochrome P450 (CYP) CYP2C9, CYP2C19 and CYP4A6 or CYP2D4 (e.g. anti-epileptic drugs, calcineurin inhibitors, anti-fungal)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites time to Cmax

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites last detection time

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites area under the curve

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites renal clearance

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites dialytic clearance

Timeframe: 48 hours

Cannabidiol and its metabolites maximum concentration (Cmax)

Timeframe: 48 hours

Trial details

NCT IDNCT05742724

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-16

View on ClinicalTrials.gov More Cannabis trials

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. adult age\>25 years
. estimated glomerular filtration rate (eGFR)\>60ml/min/1.73m2 or eGFR\<60ml/min/1.73m2 by the CKD Epidemiology Collaboration equation including in-center hemodialysis at least 2x weekly for a minimum of 3 hours per treatment via a tunnelled catheter treated \>90 days
. agree to take the medication as directed in the study
. provides informed consent

Exclusion criteria

. body mass index \<20 or \>35kg/m2
. physical dependence on any drug other than caffeine or nicotine
. history of clinically significant adverse event associated with cannabis intoxication
. history of psychosis or mania or any active major psychiatric disorder
. recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids
. taking any medication with known interactions with THC or CBD via cytochrome P450 (CYP) CYP2C9, CYP2C19 and CYP4A6 or CYP2D4 (e.g. anti-epileptic drugs, calcineurin inhibitors, anti-fungal)

What they're measuring

Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites time to Cmax

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites last detection time

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites area under the curve

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites renal clearance

Timeframe: 48 hours

Tetrahydrocannabinol and its metabolites dialytic clearance

Timeframe: 48 hours

Cannabidiol and its metabolites maximum concentration (Cmax)

Timeframe: 48 hours