UBC and Tilray Partner for Cannabis PTSD Clinical Trial

The University of British Columbia Okanagan and Tilray, a Health Canada Licensed Producer under the Marijuana for Medical Purposes Regulations (MMPR), recently announced that they have partnered to conduct a clinical trial evaluating medical cannabis in post-traumatic stress disorder (PTSD).

This will be the country’s first clinical trial to evaluate cannabis’ therapeutic benefits as a treatment for PTSD. The UBC-Tilray study, which is pending regulatory approvals, is poised to be one of the world’s first large-scale clinical trial examining medical cannabis as a treatment for a mental health disorder.

The Phase II trial will evaluate the safety and efficacy of various medical cannabis strain combinations to manage chronic, treatment-resistant PTSD symptoms resulting from trauma experienced by veterans, first responders, and sexual assault victims. The trial will be placebo-controlled, randomized, triple blind and crossover to gather evidence about the different combinations. Symptoms of chronic PTSD 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,” said Associate Professor Zach Walsh, the principal investigator for the study, a clinical psychologist, and a co-director of the UBC Centre for the Advancement of Psychological Science and Law in the Irving K. Barber School 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,” said 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.”

The study will include 40 participants who meet critical criteria for PTSD due to trauma experienced during military service, as a first responder or as the result of a sexual assault.

“Tilray’s medical cannabis is already helping Canadian veterans and former RCMP officers cope with PTSD symptoms such as insomnia and anxiety,” said 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.”

Tiilray will provide financial and coordination support for the study, as well as donate several different medical cannabis strain combinations with varying levels of THC and CBD to be administered to study participants through vaporizers. According to the company, the trial is expected to launch early next summer, pending regulatory approvals, and is scheduled to conclude in late 2016.

Source: Tilray

Last updated: 11/18/14; 2:25pm EST