As many veterans struggle with PTSD, the U.S. Food and Drug Administration (FDA) now allows researchers to explore the potential benefits of cannabis in a controlled study.
With cannabis already being used by some veterans, this trial will provide much-needed data to guide future treatment options. If you’re curious about how this could impact veterans and PTSD treatment, here’s what you need to know.
FDA Approves Cannabis Trials for PTSD in Veterans
The FDA has approved a clinical trial for veterans with PTSD, allowing the Multidisciplinary Association for Psychedelic Studies (MAPS) to move forward with its study.
On November 7, 2024, the FDA approved the Phase 2 study of cannabis for veterans with PTSD (MJP2) to proceed with smoking as a delivery method.
It will test the effects of smoked cannabis on 320 Veterans who have moderate to severe PTSD. Participants, who have previously used cannabis, will use high THC dried cannabis flower or a placebo, adjusting their daily doses themselves.
The study is funded by the Michigan Veteran Marijuana Research Grant Program. (ref)
FDA & MAPS Resolve Disagreements on Cannabis PTSD Study
Over three years, the FDA placed five partial holds on the MJP2 study, delaying its progress. On August 23, 2024, MAPS filed a Formal Dispute Resolution Request (FDRR) to address key disagreements with the FDA. (ref)
The MJP2 study is designed to help a better understanding of the safety and effectiveness of real-world cannabis use. It focuses on common consumption methods, doses, and THC content.
As cannabis laws change, it’s necessary to study its risks and benefits for public health. MAPS is committed to conducting thorough research and working to remove barriers that limit this important work.
Studying Real-World Cannabis Use for PTSD
As cannabis becomes more accessible to PTSD patients, studying how it’s used in real life is crucial.
The FDRR indicates that by 2024, medical cannabis is legal in 38 states, and 24 states have legalized recreational cannabis. Thirty states allow cannabis for PTSD, and others give doctors the discretion to prescribe it.
The FDRR also notes that the lack of high-quality research on cannabis is partly due to legal and regulatory barriers. Many researchers avoid the Investigational New Drug (IND) process (ref) and instead direct patients to local dispensaries, leading to inconsistencies in product quality and making it harder to gather reliable data.
The approval letter from the FDA was a “Continued Partial Clinical Hold” letter because it still requires more information on the safety of the vaporization device. (ref) However, MAPS successfully resolved earlier concerns about vaping.
Moving Ahead for Better Cannabis Research on PTSD
Without high-quality data on cannabis, much of the available information focuses only on risks, ignoring potential benefits. About 85% of Americans support legalizing medical marijuana, (ref) and around 52.5 million people, or 19%, used it at least once in 2021. (ref)
The FDA’s updated stance (ref) shows they are now willing to recognize the importance of gathering reliable data to understand both the risks and benefits of cannabis for treating PTSD.
The study now moves forward, and MAPS will continue to provide the FDA with details to potentially add vaporization as another option for participants.
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Martha A. Lavallie
Martha is a journalist with close to a decade of experience in uncovering and reporting on the most compelling stories of our time. Passionate about staying ahead of the curve, she specializes in shedding light on trending topics and captivating global narratives. Her insightful articles have garnered acclaim, making her a trusted voice in today's dynamic media landscape.
