Cannabis for Palliative Care in Cancer

Exclusion Criteria13

• Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
• Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
• Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
• Current use of anti-psychotic medications
• Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
• Liver function tests (Alanine transaminase \[ALT\] and Aspartate transaminase \[AST\]) levels ≥2x the upper normal limits
• Moderate or severe liver disease
• Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
• History of seizures
• For female participant of childbearing potential: Pregnant or lactating at the time of study enrollment or trying to become pregnant. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
• Physician response to passive consent indicating contraindications for participation.
• Unwilling to refrain from cannabis use other than study drug for the entire study duration
• Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day