Cannabis for Palliative Care in Cancer

Eligibility Criteria

• 1. Able to provide informed consent
• 2. Aged ≥25 years at Visit 1 (Baseline)
• 3. Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months
• 4. Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
• 5. Desire to use cannabis to treat their symptoms
• 6. Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months
• 7. Willing to practice acceptable methods of birth control until completing study medication
• 1. Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
• 2. Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
• 3. Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
• 4. Current use of anti-psychotic medications
• 5. 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)
• 6. Liver function tests (Alanine transaminase \[ALT\] and Aspartate transaminase \[AST\]) levels ≥2x the upper normal limits
• 7. Moderate or severe liver disease
• 8. Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
• 9. History of seizures
• 10. 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
• 11. Physician response to passive consent indicating contraindications for participation.
• 12. Unwilling to refrain from cannabis use other than study drug for the entire study duration
• 13. Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day