None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate whether a vaporised form of medicinal cannabis is feasible and effective in increasing appetite in cancer patients with anorexia. Who is it for? You may be eligible for this trial if you are aged 18 or over, have an advanced cancer and have been suffering from anorexia for at least two weeks. Study details: Participants will receive a range of doses of vaporised botanical cannabis flower bud one hour before your meals (three times a day) for 7 days unless side effects occur. Each dose may be different from the previous dose, but they will all be made up to the same weight of plant material by adding different amounts of inactive plant material (‘placebo’, which has the same characteristics of leaf cannabis with the active components removed). Participants will have blood samples taken at multiple timepoints up to 4 hours following each morning dose and will complete a number of questionnaires and a daily food record to determine the concentration of the drug in the blood, and to monitor its effect on appetite, mood and other factors. It is hoped that the findings from this trial will provide information on whether inhalation of medicinal cannabis is feasible for achieving a safe and effective blood concentration for the treatment of anorexia in cancer patients.
Interventions
Botanical cannabis flower bud (Bedrobinol, Bedrocan) administered via inhalation by vaporiser, taken 3 times a day, 1 hour before meal times.at study site under supervision of trials staff. Each dose level is administered for either one or two days as indicated below in a specific order which is the same for all participants, namely:
50 mg Placebo leaf, 0 mg Delta-9-tetrahydrocannabinol (THC) (one day)
8 mg Bedrobinol (dose 1) mixed with 42 mg placebo leaf, 1.08 mg THC (one day)
16 mg Bedrobino
Botanical cannabis flower bud (Bedrobinol, Bedrocan) administered via inhalation by vaporiser, taken 3 times a day, 1 hour before meal times.at study site under supervision of trials staff. Each dose level is administered for either one or two days as indicated below in a specific order which is the same for all participants, namely: 50 mg Placebo leaf, 0 mg Delta-9-tetrahydrocannabinol (THC) (one day) 8 mg Bedrobinol (dose 1) mixed with 42 mg placebo leaf, 1.08 mg THC (one day) 16 mg Bedrobinol (dose 2) mixed with 34 mg placebo leaf, 2.16 mg THC (one day) 32 mg Bedrobinol (dose 3) mixed with 18 mg placebo leaf, 4.32 mg THC (two days) 50 mg Bedrobinol (dose 4), 6.75 mg THC (two days)
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Age 18 years or above; 2) Advanced cancer; 3) Anorexia for at least 2 weeks (defined as numeric rating scale [0 no appetite – 10 best possible appetite] score less than or equal to 4) unresponsive to the optimisation of treatment of causative medical conditions 4) English-speaking (or have an interpreter available); 5) Performance status (Australia-modified Karnofsky Scale score) of 40 or above; 6) Written informed consent.
Exclusion criteria
1) Hepatic impairment (Child’s Stage B) 2) Renal impairment (estimated glomerular filtration rate of <10 mL/min) 3) Cognitive impairment (Montreal Cognitive Assessment (MOCA score<26); 4) Psychiatric disorders (severe depression or anxiety, personality disorder, history of psychosis, schizophrenia, and/or suicidal ideation); 5) Acute delirium or delirium within < 30 days; 6) Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure); 7) Impaired pulmonary function which prohibits use of vaporiser; 8) Prior adverse reaction to botanical cannabis/pharmaceuticals containing cannabinoids; 9) Pregnant, breastfeeding or unwillingness to use oral contraceptives; 10) Substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, benzodiazepines or simulants (excluding caffeine, tobacco). 11) Recent use of cannabis or cannabinoids within < 30 days (based on self-report and urine drug screen at eligibility). 12) Prescribed opioid, benzodiazepine, antidepressant, antipsychotic, corticosteroid, progestin, omega fatty acids and/or dietary supplements, which do not meet the criteria for therapies allowed at eligibility assessment 13) Participation in a clinical trial of another chemical entity. 14) Conditions causing irreversible or blood transfusion dependent anaemia where the volume of blood sampling required for this study is contraindicated in the opinion of the treating clinician.
Outcome results
None listed