The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: McMaster University
• Collaborator: Center for Medicinal Cannabis Research
• Treatments: Cannabidiol; Dronabinol; Nabiximols

Criteria

Inclusion Criteria:

1. adult age>25 years

2. 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

3. agree to take the medication as directed in the study

4. provides informed consent

Exclusion Criteria:

1. body mass index <20 or >35kg/m2

2. physical dependence on any drug other than caffeine or nicotine

3. history of clinically significant adverse event associated with cannabis intoxication

4. history of psychosis or mania or any active major psychiatric disorder

5. recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids

6. 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)

7. evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio<1.5)

8. pregnant or breastfeeding women

9. change in ideal body weight or dry weight in the last 4 weeks

10. intradialytic hypotension (systolic blood pressure<90mmHg) requiring an intervention in the previous 4 weeks