The FDA has approved a clinical trial to examine whether smoking cannabis can effectively treat PTSD in Veterans. Organized by the California-based Multidisciplinary Association for Psychedelic Studies, MAPS, the study will involve 320 Veterans diagnosed with moderate to severe PTSD. Participants will use either cannabis or a placebo and report their symptoms through a mobile app.
The five-week trial will explore the safety and potential therapeutic benefits of cannabis for PTSD. Participants, all with prior cannabis experience, will receive a maximum daily dose of 1.5 grams and adjust their usage based on personal needs, reflecting real-world consumption patterns.
MAPS emphasized that the study is not therapy-based and will not include mental health counseling. Instead, the focus is on collecting data about cannabis’s real-world safety and effectiveness in treating PTSD symptoms.
PTSD affects approximately 6 percent of adults in the United States, with Veterans facing disproportionately higher rates due to combat exposure and other traumatic experiences. Common symptoms include anxiety, depression, and flashbacks. Some Veterans report that traditional medications fail to address their symptoms, while cannabis provides relief. Many hope this study will lead to cannabis becoming an approved and covered treatment option for PTSD.
The FDA’s approval comes after years of negotiations with MAPS regarding study protocols. Issues included concerns about high-potency cannabis and allowing participants to self-regulate their doses. The approval reflects a gradual shift toward recognizing the potential therapeutic benefits of cannabis, despite its continued classification as a Schedule I substance under federal law. MAPS noted that the study aims to align with real-world usage, providing a clearer understanding of how cannabis may help manage PTSD symptoms.
An earlier pilot study conducted by MAPS suggested that inhaled cannabis could alleviate PTSD symptoms, though results were not statistically significant compared to a placebo. The upcoming trial, funded by the Michigan Veteran Marijuana Research Grant Program, will use higher-potency cannabis products similar to those commercially available in California and other states. Participants will document their experiences using a mobile app, enabling researchers to gather critical data for future studies.
Sites in California and other locations will contribute to evaluating the safety and efficacy of cannabis for PTSD treatment. Findings may pave the way for expanded treatment options for Veterans and greater acceptance of cannabis as a medical therapy. Final preparations are underway, and the study is expected to begin soon under FDA oversight.
The Biden administration recently proposed reclassifying cannabis to a Schedule III drug, which could reduce regulatory barriers. The Trump administration, however, has not yet provided clear guidance on cannabis research, leaving questions about how federal policy might evolve under Trump’s second term.