In a historic decision, the United States Drug Enforcement Agency has granted approval for the first ever U.S. clinical trial on the use of whole plant marijuana to treat the symptoms of post-traumatic stress disorder. The study, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), will test smoked botanical cannabis in a randomized controlled trial to determine its efficacy in helping veterans struggling to move past war-time traumas. With the DEA approval in hand, the study has now gained a go-ahead from every relevant federal agency, including the Food and Drug Administration, the National Institute on Drug Abuse, and the Public Health Service.
There is ample anecdotal evidence that smoking marijuana can help veterans struggling with PTSD, but the federal prohibition on cannabis and accompanying byzantine obstacles posed to scientific research have blocked the advancement of full clinical trials — until now. MAPS has been working to get the research off the ground for years, and finally the scientists have a green light to get started.
“We have been working towards approval since we opened the Investigational New Drug Application (IND) with the FDA in 2010,” Amy Emerson, Executive Director and Director of Clinical Research for the MAPS Public Benefit Corporation, said in a press release. “We are thrilled to see this study overcome the hurdles of approval so we can begin gathering the data. This study is a critical step in moving our botanical drug development program forward at the federal level to gather information on the dosing, risks, and benefits of smoked marijuana for PTSD symptoms.”
The study will look at the effects of smoked marijuana on 76 veterans who suffer from chronic, treatment-resistant PTSD, and document what effect the medicine has on their symptoms. The research aims to dig even deeper by testing four separate strains of marijuana to compare dosing, composition, side effects, and areas of benefit between plants with varying levels of tetrahydrocannabinol (THC) and cannabidiol (CBD).
Currently, the U.S. Department of Veterans Affairs prohibits doctors from prescribing marijuana to patients even in states where it is legal, noting on their website that “controlled studies have not been conducted to evaluate the safety or effectiveness of medical marijuana for PTSD.” The work that MAPS is conducting aims to change that, laying the groundwork to potentially rationalize federal law and policy related medical marijuana.
Already, a substantial but unknown number of veterans use marijuana to medicate their PTSD, but they must go around the VA system to gain access to the medicine, or simply purchase it illegally outright. In other words, soldiers who fought for the United States overseas are left with a choice of either breaking the law when they come home in order to treat disorders they picked up during their service, or living with life-altering trauma including anxiety, paranoia, and panic attacks.
Marcel Bonn-Miller, Ph.D, is the coordinating principal investigator of the MAPS study, while Ryan Vandrey, Ph.D is testing subjects at Johns Hopkins and Sue Sisley, M.D is leading the research in Phoenix. The state of Colorado awarded a grant of $2,156,000 to fund the study.