Cannabis for Improving Palliative Care Outcomes in Patients with Cancer

Inclusion Criteria

• Able to provide informed consent
• Aged ≥ 25 years at visit 1 (baseline)
• 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
• Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
• Desire to use cannabis to treat their symptoms
• Must not have been regularly using any cannabis products (more than 6x/month) in the last 6 months
• Willing to practice acceptable methods of birth control until completing study medication

Exclusion Criteria

• 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)
• Alanine transaminase (ALT) and aspartate transaminase (AST) levels ≥ 2 x 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 follicle-stimulating hormone (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