The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol (POT-GFR-PK)
Cannabis, Chronic Kidney Diseases, Dialysis
About this trial
This is an interventional other trial for Cannabis focused on measuring Pharmacokinetics
Eligibility Criteria
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) evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio<1.5) pregnant or breastfeeding women change in ideal body weight or dry weight in the last 4 weeks intradialytic hypotension (systolic blood pressure<90mmHg) requiring an intervention in the previous 4 weeks
Sites / Locations
- St. Joseph's Healthcare HamiltonRecruiting
Arms of the Study
Arm 1
Experimental
THC/CBD
Oral THC 0.1mg/kg and CBD 2.5mg/kg