UBC and Tilray Partner for Canada’s First PTSD Cannabis Study
Research to examine medical benefits for veterans, first responders and sexual assault survivors
NANAIMO, British Columbia–(BUSINESS WIRE)–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.
“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 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.
About the University of British Columbia
The University of British Columbia UBC is a global centre for research and teaching, consistently ranked among the 40 best universities in the world. The Okanagan campus is home to 8,388 students, while the Vancouver campus has a student population of 49,896. Research funding at UBC totaled $564 million for 8,442 projects in 2013/14, including $16.4 million for more than 600 projects at UBC Okanagan.
About Tilray
Tilray (www.tilray.ca) is a leading premium medical cannabis company, offering unparalleled quality and consistency for patients who use and physicians who prescribe medical cannabis.
Post source Business Wire
B.C. medical marijuana producer hopes to sponsor PTSD study
Trial would be conducted by UBC researchers in Kelowna
A B.C. medical marijuana producer is seeking approval from Health Canada to sponsor the first study in Canada on the safety and effectiveness of cannabis for post-traumatic stress disorder (PTSD) among sexual assault victims, military veterans and first responder personnel.
The Nanaimo medical marijuana facility called Tilray — one of about 20 Health Canada-licensed producers in the country — is sponsoring the $350,000 study. It would be conducted by University of B.C. researchers at the Kelowna campus and would require UBC ethics board approval. If the study overcomes regulatory hurdles, recruitment of participants with PTSD would begin early next year.
Zach Walsh, a UBC psychology professor who would be the study’s principal investigator, said marijuana is used by an unknown proportion of PTSD patients for symptoms including flashbacks, anxiety, depression, anger, irritability and changes in sleep and appetite. Yet there is a paucity of scientific evidence about therapeutic benefits or risks of use.
“Physicians and patients are hungry for research on marijuana. Medical research is playing catch-up with cannabis use so we really need to do these kinds of controlled studies,” said Walsh, who is a co-director for UBC’s Centre for the Advancement of Psychological Science and Law. “My professional interest is in developing effective therapies for psychological disorders.”
It’s not known how many PTSD patients use cannabis but a 2008 Canadian study estimated that 9.2 per cent of the population will suffer from the extreme anxiety disorder at some point in their lifetime. At any time, 2.4 per cent of people have symptoms as a result of experiencing or witnessing major trauma.
Standard treatment often involves the use of powerful antidepressants, antipsychotics, sleeping pills and other drugs, many of which are “not harmless” since they have unwanted side effects, Walsh noted. While cognitive behavioural therapy is the gold standard, not all patients can afford it or get it. That’s partly why many turn to self-medicating with substances like marijuana, and observational studies or case reports have shown some benefits.
“But this has been a patient-led movement. The medical establishment has trailed with research,” he said.
Walsh said marijuana can also have unwanted side effects, such as bronchial problems or cognition difficulties (memory, paranoia) but researchers and medical dispensary experts believe that may be a function of which strains and delivery methods are used.
“I think the best medical marijuana dispensaries have actually done a remarkably good job of matching strains to patients’ experience. They’ve got the dedication and expertise and really listen to patients. They take their jobs seriously,” Walsh said.
Philippe Lucas, vice-president of patient research at Tilray, said the value of the cannabis supplied by his firm will be about $40,000 (or $1,000 for each of the 40 study participants) but it’s a complex study to organize so various staff will be hired by UBC researchers to co-ordinate the logistics.
Participants will pick up their marijuana and vaporizers at a secure location in the Kelowna area and must return to the lab weekly, so it’s expected most participants will be residents of the B.C. interior region.
Those selected for the trial will have to undergo a two-week “washout” period before starting the trial, which means they will have to stop using marijuana if they are already doing so. Washouts will also take place each time they change strains, but participants, researchers and independent reviewers will be blinded to the strains of cannabis to guard against bias.
Lucas said he doesn’t expect there will be any difficulty finding PTSD patients for the study. Tilray already has 150 customers with PTSD who buy their products, including military veterans and former RCMP officers.
He said Tilray is the first and only Health Canada medical marijuana-licensed producer to announce an intention to conduct a clinical trial for a mental health ailment. Tilray opened its production facility to grow and distribute medical cannabis for Canadian patients in April 2014. The $20-million facility claims to employ more than 100 scientists, botanists and horticulturalists.
To express interest in the trial or learn more about it, email tilray@tilray.ca
To learn more about PTSD, visit this Canadian Mental Health Association page or visit our recent series on the topic.
Sun Health Issues Reporter
Follow me: @MedicineMatters
Article source Vancouver Sun
UBC Okanagan and medical cannabis producer team up for clinical study
Don Plant
UBC Okanagan has announced a study it hopes will prove that using marijuana benefits people with post-traumatic stress disorder.
If approved by Health Canada, the clinical trial would be the first in North America to examine medical cannabis as a safe treatment for a mental-health disorder.
“I’m very excited. It has the potential to find effective treatments for people who are really suffering,” said Associate Prof. Zach Walsh, a clinical psychologist at UBCO and the study’s principal investigator.
Those people would include survivors of sexual assault, military veterans, police and other first responders. Many of them suffer flashbacks, anxiety, depression, anger and disrupted sleep.
New Brunswick Mountie Cpl. Ron Francis, who said he smoked marijuana on the job to reduce his symptoms of PTSD, was awaiting sentencing for three offences when it’s believed he took his own life last month.
The university has teamed up with Tilray, one of the few licensed producers of medical marijuana in Canada. The Nanaimo-based facility has applied to Health Canada to sponsor the $350,000 study.
Researchers at UBCO must get approval from the university’s ethics board to launch the clinical trial. If they get the green light, they plan to recruit 40 adults with PTSD from the Okanagan and Southern Interior. Some of them may already be using marijuana.
“Physicians and health-care professionals are really desperate for more research on medical cannabis. The patients are ahead of the research in this area, and we need research to catch up,” Walsh said.
Most researchers are reluctant to study the medical benefits of marijuana because it contains hundreds of compounds that vary widely from plant to plant.
Growers at Tilray can produce strains of cannabis that contain varying amounts of active ingredients like THC and CBD, Walsh said. Participants in the study would stop using marijuana two weeks before it begins. They would receive a weekly amount of cannabis, which they take home and ingest by inhaling through a vapourizer.
Strains would have either high concentrations of THC (the principal psychoactive constituent), CBD (considered to have more medical applications than THC), or equal amounts of both. A control group would get a placebo.
Those selected for the study, the investigator and the people who administer it will be “blind” to what treatment each participant gets to prevent bias.
Applicants must be screened for psychosis, which is unsuited to cannabis therapy. Those selected would record their usage and speak with a researcher when they pick up a fresh batch of cannabis each week. They’d participate for three or four months.
Proponents claim that cannabis helps reduce the negative memories associated with a traumatic event. Studies with rodents subjected to a loud bang or shock have shown the animals suffer shocks triggered even by a neutral stimulus. Those given cannabis show reduced symptoms, Walsh said.
“Between basic science, animal studies and anecdotal reports, there’s a pretty strong basis to take this research to the next step and do a clinical trial.”
The study is expected to launch in early summer, pending the regulatory approvals, and to conclude in late 2016.
Article source Kelowna Daily Courier
