Bedrocan’s cannabis used in clinical trial Australia

The first of its kind in Australia, Bedrocan’s cannabis flos and placebo will be used in a advanced cancer palliative care clinical trial. Led by Professor Meera Agar, the double-blind randomised controlled trial will explore whether vaporized medicinal cannabis flos can promote appetite and improve quality of life. For people with advanced cancer, the pathways that promote appetite are disrupted. Their quality of life is reduced due to fatigue, low mood, nausea and insomnia – aspects critical to health and wellbeing.

Advanced cancer

This stage 1 trial is now complete and is no longer enrolling new participants. Approximately 30 adult patients with advanced cancer were included in the trial undertaken at Sydney’s St Vincent’s Sacred Heart Health Service and Newcastle’s Calvary Mater Hospital.

Participants were administered increasing doses of the vaporized Bedrobinol® (THC: 13.5%) one hour before meals three times a day for a period of seven days, unless side-effects occurred. Participants had blood samples taken at multiple time points up to four hours following each morning dose to determine the concentration of the drug in the blood. They were also asked to complete questionnaires and a daily food record to monitor the effect on appetite, mood and other factors. The study findings are being finalised for publication.

Namisol

The second stage of the program uses an oral tablet of THC called Namisol® produced by Echo Pharmaceuticals, a medicinal cannabis company in the Netherlands. Stage 2 study aims to determine if oral delta-9-tetrahydrocannabinol (THC) can improve anorexia-related symptoms and concerns in people with advanced cancer compared to placebo in a double-blind randomised clinical trial.

Anorexia is the second most common condition in advanced cancer, affecting up to 90% of sufferers. Current pharmacological therapies for anorexia include progestins and corticosteroids, which provide limited and short-term improvements in appetite, weight or food enjoyment; and use is often limited by side effects.

This stage is occurring across multiple sites across metropolitan and regional NSW and may enrol up to 250 participants.

Medicinal cannabis clinical trials

The New South Wales Minister for Medical Research, the Hon. Pru Goward, fully supports the trial as part of the state Government’s $21 million funding commitment to medicinal cannabis clinical trials and reforms. To learn about the NSW Government’s Centre for Medicinal Cannabis Research and Innovation and the trial see www.medicinalcannabis.nsw.gov.au.

Not all vaporizers are the same

For more on vaporization as a way of administering cannabis flos, read the article Not all vaporizers are the same.