Inclusion
• Age greater than or equal to 18 years;
• Advanced cancer;
• Anorexia for at least 2 weeks (defined as numeric rating scale [0 no appetite – 10 best possible appetite] score greater than or equal to 4) unresponsive to the optimisation of treatment of causative medical conditions
• English-speaking (or have an interpreter available);
• Written informed consent.
Exclusion
• Inability to take medications sublingually
• Severe hepatic impairment (defined as bilirubin greater than or equal to 3 times upper limit of normal; aspartate transaminase and/or alanine transaminase > 5 times upper limit of normal) clinically determined to be due to hepatic impairment
• Renal impairment (estimated glomerular filtration rate of <10 mL/min)
• Cognitive impairment (Montreal Cognitive Assessment (MOCA score<26);
• Psychiatric disorders (severe depression or anxiety, personality disorder, history of psychosis, schizophrenia, and/or suicidal ideation);
• Acute delirium or delirium within < 30 days;
• Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure);
• Prior adverse reaction to botanical cannabis/pharmaceuticals containing cannabinoids;
• Pregnant, breastfeeding or unwillingness to use oral contraceptives;
• Substance use disorder (DSM 5 criteria; to alcohol, opioids, benzodiazepines or simulants (excluding caffeine, tobacco).
• Recent use of cannabis or cannabinoids within < 30 days (based on self-report and urine drug screen at eligibility).
• Prescribed opioid, benzodiazepine, antidepressant, antipsychotic, corticosteroid, progestin, omega fatty acids and/or dietary supplements, which do not meet the therapies allowed at eligibility assessment
• Current participation in a clinical trial of another chemical entity.