Tilray, a global leader in medical cannabis research and production, and the University of British Columbia today announced that patient recruitment for Canada’s first clinical trial to evaluate the therapeutic potential of medical cannabis as treatment for post-traumatic stress disorder (PTSD) will begin this month. This trial will be one of the world’s first large-scale clinical trials to examine medical cannabis as a treatment for a mental health disorder, and the largest medical cannabis clinical trial to take place in Canada in the last 40 years. The trial has received all necessary regulatory and institutional review board approvals and will begin as soon as patients are enrolled.
“We know there continues to be significant unmet need in the treatment of PTSD in Canada and around the world,” says study principal investigator and clinical psychologist Zach Walsh, an Associate Professor at UBC’s Okanagan campus in Kelowna, which is hosting the study. “This trial will allow us to build on the anecdotal evidence supporting the potential use of medical cannabis to treat PTSD and hopefully help those who struggle with this debilitating condition. We are glad that people who suffer from PTSD may be eligible to take part in this cutting-edge study.”
The Phase II, triple-blind, placebo-controlled, randomized, crossover clinical trial will gather evidence on the safety and efficacy of three potencies of medical cannabis (10% THC, 10%THC/CBD, and a placebo) to manage chronic, treatment-resistant PTSD symptoms resulting from a traumatic event. While the main treatments for people with PTSD are psychotherapy, medications, or both, many patients continue to struggle with the effects of PTSD. There is promising preclinical and anecdotal evidence supporting the potential of medical cannabis to alleviate PTSD symptoms, particularly among veterans. This research will add to the state of knowledge regarding the potential risks and benefits of cannabis as a treatment for PTSD and provide critical insight about how cannabis of various chemical compositions may affect treatment outcomes.
Tilray is the first and only Health Canada-approved licensed producer to announce a clinical trial studying the medical risks and benefits of cannabis for a mental health condition. Medical cannabis used in the trial will be administered through a vaporizer that enables a non-smoked method of ingestion. “This trial will help us hone in on whether medical cannabis with different cannabinoid profiles can help alleviate the symptoms of PTSD,” says Philippe Lucas, Vice President, Patient Research and Services at Tilray. “Tilray currently supplies product to a number of patients suffering from PTSD; we anticipate that this data will enhance our ability to help these patients, and will add to the global scientific discussion around medical cannabis as a treatment for the condition.”
“Research suggests that PTSD affects over 9% of men and women in Canada, and many more worldwide,” says Trev Bungay, Vice President of Trauma Healing Centers, a patient resource center. “It is also estimated that up to 10% of Canadian war zone veterans, including war service veterans and peacekeeping forces, will experience post-traumatic stress disorder following their service. Treatment is necessary in order to help those who have served their country, or experienced an unfortunate traumatic event, find coping methods to continue to live a full and normal life.”
Study participants will include 42 Canadian men and women who meet clinical criteria for PTSD, including veterans, former first responders and law enforcement officials, and victims of sexual assault or other violence. With all regulatory approvals now in place, the trial will begin recruitment in September 2016, and is scheduled to conclude in spring 2018.
“Tilray is at the forefront of clinical research in the medical cannabis field. We are providing physicians and researchers with cannabis-derived study drugs that meet rigorous regulatory standards for human trials and are based on studies indicating a high likelihood of success in treating specific diseases and disease-related symptoms,” says Dr. Catherine Jacobson, Director of Clinical Research at Tilray. “Methodologically sound research resulting from these trials is the best tool we can offer physicians to further understand the effectiveness of medical cannabis treatment for a variety of symptoms associated with numerous illnesses and medical conditions.”
For further information on the PTSD clinical trial, please contact Zach Walsh.