World's largest medicinal cannabis clinical trial to launch in Australia
A variety of medicinal marijuana buds in jars are pictured at Los Angeles Patients & Caregivers Group dispensary in West Hollywood, California U.S., October 18, 2016. The NSW government has funded the world's largest trial of medicinal cannabis that will prevent the side effects of chemotherapy. Patients who undergo chemotherapy treatment experience nausea, vomiting and for some, bouts of oesaphigitis or inflammation of the oesephagus. Chris O’Brien Lifehouse's associate professor Peter Grimison will lead the trial. It will be in collaboration with the University of Sydney, Royal Prince Alfred Hospital and leading NSW cancer centres.
A plant-derived capsule developed by Tilray will be used in the trial. It is pharmaceutical grade containing consistent amounts of delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD). Tilray is a Canadian medicinal cannabis company.
The trial has two stages which will be performed at Chris O’Brien Lifehouse and other leading cancer sites in NSW. In this stage, it requires only 80 patients who will be evaluated after their intake the medicine. When the patients show signs that the medicine works and they are able to tolerate it, the second stage will follow. The second stage will undergo a double-blinded randomised controlled trial at several NSW hospitals. From 80 patients, the number of participants will be increased to 250. This stage will measure the symptoms experienced by participants and the relief they acquired after taking the medicine. The trial will also measure the side effects of the medicinal cannabis. The two stages will follow existing standard ethical process for clinical trials. The participants who are qualified for the trial must be over 18 years old. On the scheduled date of the trial, they must be under the chemotherapy treatment for cancer. They must also feel significant side effects during the first cycle of the treatment even after taking the best medicine recommended by their doctors. "The trial will play a critical role in developing a better understanding of how cannabis products may provide relief for cancer patients. It's amazing to think that people have been talking about this for 30 years and yet there has been no real investment in putting it up. It's come down to NSW to be a world leader, " Minister for Medical Research Pru Goward said, according to The Sydney Morning Herald. http://www.ibtimes.com.au/worlds-largest-medicinal-cannabis-clinical-trial-launch-australia-1535946