International
US: FDA authorizes study of smoked cannabis to treat PTSD in veterans
After three years of negotiations, the FDA has approved a clinical trial that will investigate, for the first time, the use of smoked cannabis to treat symptoms of post-traumatic stress disorder (PTSD) in 320 veterans in the United States. Funded by a program from the state of Michigan, the trial will be conducted by MAPS, with the aim of reflecting real-life consumption patterns and evaluating the safety and efficacy of the plant in alleviating symptoms of PTSD, a condition that affects millions of veterans.
The Food and Drug Administration (FDA) has approved a groundbreaking clinical trial that will investigate the use of smoked cannabis to treat symptoms of post-traumatic stress disorder (PTSD) in veterans. This milestone, announced by the Multidisciplinary Association for Psychedelic Studies (MAPS), comes after three long years of negotiations and initial resistance from the FDA.
The MJP2 Study: A Realist Approach
The trial, called MJP2, is a randomized, placebo-controlled Phase 2 clinical trial that will evaluate high-THC cannabis use versus placebo in 320 veterans with moderate to severe PTSD. The study, funded by the Michigan Veterans Cannabis Research Program, aims to generate safety data that reflect realistic use patterns.
Participants will be able to self-administer their cannabis dosage according to their daily needs, but within established limits. This approach, known as “self-titration,” mimics veterans’ everyday cannabis use, allowing for a more realistic assessment.
Advances after years of resistance
Since the initial proposal in 2021, the FDA has issued five partial hold letters, blocking the study from moving forward due to concerns related to the method of administration (smoked or vaporized), the level of THC, and the inclusion of participants with no prior cannabis experience. MAPS responded to each of the objections and in August 2024 submitted a Formal Dispute Resolution Request (FDRR), prompting the FDA to review its position.
The regulator is now allowing the study to proceed with high-potency, smoked cannabis, in line with products legally available in states with medical or recreational programs in place. However, the agency has maintained restrictions on vaporization devices, requiring more technical information about their safety.
Impact of the study on research and public health
The MJP2 study is seen as an opportunity to fill gaps in the scientific evidence on the use of cannabis to treat PTSD. Despite the growing popularity of cannabis among veterans and PTSD patients, rigorous studies evaluating its efficacy and safety are still needed. MAPS hopes that the data generated will inform physicians, patients, and regulators about the real-world benefits and risks of cannabis use in medical settings.
Sue Sisley, MD, principal investigator of MJP2, highlighted the urgency of the study: “Veterans often report that smoking cannabis helps them manage PTSD symptoms more effectively than traditional medications. This research is crucial to providing new treatment options and addressing the mental health crisis among veterans.”
Changing approach to regulation
The study’s approval reflects an evolution in the FDA’s stance on cannabis research. Allison Coker, director of cannabis research at MAPS, said the decision demonstrates a growing recognition of the value of the study’s data that considers both the benefits and risks of cannabis use.
MAPS continues to challenge the traditional regulatory paradigm by advocating for research that reflects real-world cannabis use rather than being limited to the rigid criteria set by the empirical community, which often excludes and renders the trial unrepresentative. Rick Doblin, founder of MAPS, said: “This is another step in breaking down barriers and paving the way for science to track the real-world impact of cannabis on health.”
The approval of MJP2 could mark a turning point in medical cannabis research. Funded with $12,9 million in Michigan cannabis sales tax revenue, the study will help set a precedent for future researchers while also promoting a more comprehensive and realistic approach to evaluating the plant as a medical treatment. With the data expected from MJP2, clinicians and regulators will be able to make more informed decisions while laying the groundwork to overcome regulatory challenges that still exist at the federal level.
This breakthrough represents not only a victory for MAPS, but also new hope for millions of people seeking alternatives to treat debilitating health conditions like PTSD.
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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages using an automatic translator. Some words may differ from the original and typos or errors may occur in other languages.]____________________________________________________________________________________________________
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I am one of the directors of CannaReporter, which I founded together with Laura Ramos. I am from the unique Island of Madeira, where I currently reside. While I was in Lisbon at FCUL studying Physical Engineering, I became involved in the national hemp and cannabis scene and participated in several associations, some of which I am still a member of. I follow the global industry and especially legislative advances regarding the different uses of cannabis.
I can be contacted by email at joao.costa@cannareporter.eu
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