First Australian medical cannabis clinical trial greenlighted

Day 266 - West Midlands Police - Cracking down on Cannabis

NSW will be the first Australian state or territory to conduct medicinal cannabis clinical trials for terminally ill adults with cancer after Premier Mike Baird gave the go-ahead to researchers at UNSW.

The NSW Government has committed $9 million to support medical cannabis clinical trials but there is no mention yet when trials treating children with severe epilepsy will begin, something Mr Baird pledged to explore last year.

The drug can be used to treat a wide range of conditions, including muscle spasms caused by epilepsy and multiple sclerosis, chemotherapy-induced nausea, Crohns disease and poor appetite caused by HIV.

University of New South Wales’ Chief Investigator Associate Professor Meera Agar – who has led several research studies into the management of terminally ill patients – will lead the research team and focus on how medicinal cannabis can improve poor appetite and appetite-related symptoms, such as nausea, in terminally ill adult cancer patients in their final stages of life.

The first part of the trial will be held at the Calvary Mater Newcastle Hospital in early 2016 and involve about 30 patients with the goal of discovering whether cannabis can be successfully inhaled as a vapour, what its side effects are and the frequency and size of the ideal dose, with initial results expected by the end of 2016.

Part two of the study could see it rolled out to major NSW regional and metropolitan hospitals with a larger number of patients. The next step will be for the research team to seek review and approval of the trial by a Human Research Ethics Committee.

Associate Professor Agar said the trial would evaluate two types of cannabis products – vaporised leaf cannabis and a pharmaceutical.

“It will be undertaken in two parts, and will assess the potential ability of cannabis to alleviate distressing symptoms including fatigue, low appetite, altered taste and smell for food, low mood, weight loss, nausea, insomnia and pain relief,” Professor Agar said.

“This will add to the existing body of evidence based research to help better understand and evaluate the potential benefits that medical cannabis products may have for terminally ill patients.”

Mr Baird said the first trial would be critical to better understanding how role medical cannabis could alleviate symptoms and pain in terminally ill patients.

“We do not want patients or carers having to play pharmacist – that is why it is so important to explore the safest and most effective ways we can deliver compassionate care and improve the quality of life,” Mr Baird said.

“Our trials will help to position NSW at the forefront of world-class research in this area and explore how we can complement the existing palliative care treatments and therapies patients receive.”

There is growing cross-party support for medicinal cannabis in many Australian states and territories after many sick people have publicly told their stories of how it has helped them control pain, nausea and seizures.

Queensland Premier Annastacia Palaszczuk and Victoria Premier Dan Andrews have both publicly backed the NSW trials Victoria and Mr Andrews has indicated he would work in partnership with NSW next year to run them, including those targeting children with serious epilepsy.

The ACT Legislative Assembly is currently considering the Greens’ draft bill to legalise medicinal cannabis, with a report expected to be ready before July 2016, while Tasmania is holding its own parliamentary inquiry into legalising medical cannabis, reporting at the beginning of 2016.

But although medicinal cannabis researchers and campaigners support clinical trials they have warned that the reality of it becoming available to seriously ill people could be many years away.

Troy Langmann is the founder of Tasman Health Cannabinoids, a company that has been trying to secure a research and development (R&D) license to grow medicinal cannabis in Tasmania and Norfolk Island. He told Government News earlier this year:

“Any positive steps are encouraging but it worries me that they may wait five years to allow this very safe medication to be distributed more widely. We know it’s safe, side effects are minimal and people prefer it over many currently prescribed medications, which in many cases are nowhere near as effective as cannabis,” Mr Langmann said.

“[Cannabis] is a complex medication – it contains over 500 different compounds and can be used for a huge variety of conditions, from depression to cancer.

“It’s just not feasible to do individual clinical studies to determine what it should be used for, for the sake of satisfying a peer reviewed study, when there is a desperate need for this medicine now.”

While NSW might be Australia’s pioneering medicinal cannabis state Australia is years behind other countries in researching and legalising the drug.

Cannabis is allowed for medical use in countries including 36 US states, France, the Netherlands, Uruguay, Chile, the Czech Republic and in Israeli hospitals and nursing homes.

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4 thoughts on “First Australian medical cannabis clinical trial greenlighted

  1. This is exciting news. This research has the potential to provide quality of life outcome for so many people. I have a daughter with Rheumatoid Arthritis who is trying to return to work after ten months leave of absence. Medical cannabis shows promise for so many conditions,including auto immune conditions such as hers. The entire body has cannabinoid receptors, with the exception of the brain stem, which is what makes it so safe. My major concern is the projected time line which is painfully protracted. The Israelis have done so much research, are breeding low THC cannabis plants, why are we not learning from them? There is also the potential for veterinary use. Why are we reinventing the wheel? I hope it’s not to help the pharmaceutical companies catch up with a synthetic product! Congratulations to Mike Baird and the NSW government for funding this.

  2. Why can’t we rely on studies done in the USA, UK and other countries who have done reliable analysis? Surely we don’t do clinical tests for every new drug that is allowed to be used in this country! My 3 year old grandson has a literal cocktail of drugs for his epilepsy and I bet they have not had to go through this regime of rigorous testing in Australia. The drugs he takes do not work and also have serious side effects which are not helping him really, where is the concern for the affect these pharmaceuticals are having on him. The low CBD marijuana may not be the answer to his problems but it would also be helpful if he could actually try them before he gets any older. Anecdotally this treatment is having a lot of success for epilepsy!

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