Research to examine medical benefits for veterans, first responders and sexual assault survivors
The University of British Columbia Okanagan and Tilray, a Health Canada Licensed Producer under the Marihuana for Medical Purposes Regulations (MMPR), will conduct the country’s first clinical trial to evaluate the therapeutic benefits of medical cannabis as treatment for post-traumatic stress disorder (PTSD). Pending regulatory approvals, the UBC-Tilray study is poised to be one of the first in the world to run a large-scale clinical trial examining medical cannabis as a treatment for a mental health disorder.
The Phase II, placebo-controlled, randomized, triple blind, crossover clinical trial will gather evidence about the safety and efficacy of different medical cannabis strain combinations to manage chronic, treatment-resistant PTSD symptoms resulting from trauma experienced by veterans, first responders, and sexual assault survivors. Chronic PTSD symptoms include flashbacks, anxiety, depression, anger, irritability, and changes in sleep and appetite.
“Even with current treatments, many patients continue to struggle with the debilitating effects of PTSD,” says Associate Professor Zach Walsh, the principal investigator for the study, a clinical psychologist, and co-director of the UBC Centre for the Advancement of Psychological Science and Law in the Irving K. Barber School of Arts and Sciences. “There is promising preclinical and anecdotal evidence supporting the potential of medical cannabis to alleviate PTSD symptoms, particularly among veterans. We have an ethical responsibility to examine all possible treatment options to ease their suffering.”
“Physicians and patients have been asking for more scientific evidence to inform their decisions about medical cannabis. The results of this study will give them more information rooted in clinical research,” says Dr. Ian Mitchell, a co-principal investigator for the study, a practicing emergency room physician and site scholar for the Kamloops Family Medicine Residency program with UBC’s Southern Medical Program. “Many patients with PTSD have symptoms that are terribly disruptive to their lives and often poorly treated with current therapies. We need new and better treatment options.”
Study participants will include 40 Canadian men and women who meet clinical criteria for PTSD (DSM-V) due to trauma experienced during military service, as a first responder, or as the result of sexual assault. The trial is expected to launch in early summer 2015, pending necessary regulatory approvals, and is scheduled to conclude in late 2016.
“Tilray’s medical cannabis is already helping Canadian veterans and former RCMP officers cope with PTSD symptoms such as insomnia and anxiety,” says Philippe Lucas, vice president for patient research and services at Tilray. “This clinical trial will provide physicians worldwide with scientific data to make informed decisions about providing PTSD patients proper treatment.”
Tilray is the first and only Health Canada MMPR Licensed Producer to announce clinical trials studying the medical benefits of cannabis for a mental health disorder. Tilray will provide financial and coordination support for the study, in addition to donating several different medical cannabis strain combinations with varying levels of THC and CBD to be administered to patients participating the study through vaporizers – a non-smoke method of ingestion.
“The UBC-Tilray trial will enable us to learn more about the science of cannabis as therapy for PTSD,” says Dr. Joshua Eades, chief science officer at Tilray. “The use of strains with varying cannabinoid profiles will help us understand more about which cannabinoids are most effective at alleviating PTSD symptoms in veterans, first responders and trauma victims.”
Tilray opened a state-of-the-art research and production facility to grow, process, package and ship medical cannabis for Canadian patients in April 2014. Located in Nanaimo, British Columbia, the $20 million, 60,000-square-foot facility employs more than 100 Canadians including research scientists, botanists, and horticulturalists who are industry leaders in medical cannabis research and related agricultural sciences.