Following a three-year-long fight, the U.S. Food and Drug Administration has finally given its blessing to a proposed clinical trial to study the efficacy of medical marijuana for military veterans who are smoking or vaping cannabis to treat post-traumatic stress disorder.
The study, formally called MJP2, was only greenlit by the FDA this week after years of relentless lobbying by the Multidisciplinary Association for Psychedelic Studies (MAPS), the nonprofit announced in a press release. The study was first reported by The New York Times.
The FDA rejected the approval request for cannabis-based clinical trials five times with “partial clinical hold letters,” but MAPS kept hammering and finally won after it said internal changes were made at the agency’s Division of Psychiatry and in its work on cannabis, the organization said.
“Through persistent, evidence-based disputes, MAPS won clearance to conduct the first clinical trial that will study cannabis as a treatment in a way that reflects real-world cannabis use,” MAPS said.
MAPS asserted that the Division of Psychiatry originally asserted it would only condone a PTSD study of veterans who were not smoking or vaping cannabis, and it wouldn’t consider any clinical trials with higher-potency marijuana that can be found commonly in a lot of U.S. state-legal markets, despite the study having won state approval back in 2021.
In August, MAPS submitted a dispute resolution request, which ultimately persuaded the agency to sign off on the study, as long as the participants have some experience already in smoking or vaping marijuana.
Now that approval has been granted, the study is set to move forward with 320 veterans and $12.9 million in state funding from the Michigan Veteran Marijuana Research Grant Program and the state Cannabis Regulatory Agency.
“Despite the increasingly widespread use and acceptance of cannabis in patients with PTSD, labeled as ‘medical use’ in many states, there is still a lack of high-quality, controlled data on the safety and effectiveness of cannabis use that reflects real-world consumption patterns,” Dr. Allison Coker, director of cannabis research at MAPS, said in the release. “MAPS designed MJP2 to bridge this evidence gap by studying the ‘real-world’ use of inhaled cannabis to understand its potential benefits and risks in treating PTSD.”
Dr. Sue Sisley, another well-known cannabis researcher who will help run the trials, added that the upcoming study will “generate data that doctors, like myself, can use to develop treatment plans to help people manage their PTSD symptoms.”
“In my own practice, veteran patients have shared how smoking cannabis helped them manage their PTSD symptoms more than traditional pharmaceuticals,” Sisley said. “Suicide among veterans is an urgent public health crisis, but it’s solvable if we invest in researching new treatments.”
H/T: www.greenmarketreport.com
