Breaking Barriers: How Cannabis Research for Veterans with PTSD Faces Regulatory Hurdles

For thousands of veterans returning from combat zones, the battlefield doesn't end when they come home. The invisible wounds of Post-Traumatic Stress Disorder (PTSD) can haunt them for years, disrupting sleep, triggering flashbacks, and making everyday life feel like walking through a minefield of potential triggers. While traditional treatments help some, many veterans continue to struggle. Could cannabis offer relief where other treatments have failed? That's the question researchers at the Multidisciplinary Association for Psychedelic Studies (MAPS) have been trying to answer. But as with many studies involving substances that remain federally controlled, the path to answers isn't straightforward.

The Regulatory Dance: MAPS and the FDA

In January 2025, MAPS submitted important paperwork to the Food and Drug Administration (FDA) regarding their Phase 2 study of smoked cannabis for veterans with PTSD. This wasn't just routine paperwork – it represented a critical step in a years-long struggle to conduct this research. MAPS submitted their 2024 Cannabis Data Safety Update Report (DSUR) along with a protocol amendment. The DSUR serves as the annual report to the FDA on how the drug investigation has progressed over the past year. But progress has been slow, largely because the study remained on clinical hold until November 7, 2024."The regulatory hurdles for cannabis research are unlike anything we see with other medications," explains a researcher familiar with the process. "Even when the potential benefits for suffering patients seem clear, the path forward is often blocked by red tape."

Smoking vs. Vaporizing: A Regulatory Sticking Point

One of the most interesting aspects of this story involves how cannabis is administered in the study. The FDA finally cleared the study to proceed in November 2024, but with a catch – only smoking would be permitted as the administration method for the cannabis. This might seem counterintuitive. After all, isn't smoking generally considered more harmful than vaporizing? The FDA actually agreed that both smoking and vaporization of cannabis flower were acceptable methods that don't pose unreasonable risk for PTSD patients. However, they required additional physical, mechanical, and safety information about the vaporization device itself before allowing that option in the study. Rather than delay the research further, MAPS made a practical decision. They submitted updated protocol and informed consent form amendments that removed the vaporization option, allowing clinical sites to have a clear protocol for starting the study. Meanwhile, they plan to provide the FDA with the additional device information in hopes of adding the vaporization option before recruitment begins. This detail highlights how even seemingly small aspects of research design can become major roadblocks when studying controlled substances.

Why This Research Matters

For veterans struggling with PTSD, this research isn't just an academic exercise – it could potentially open doors to relief that has eluded them through conventional treatments. PTSD can manifest in various debilitating symptoms, including:

• Intrusive memories and flashbacks
• Severe anxiety and hypervigilance
• Sleep disturbances and nightmares
• Emotional numbness and detachment
• Intense distress when reminded of traumatic events

Current treatments, which typically include therapy and medications like SSRIs, don't work for everyone. Some veterans report that cannabis helps reduce nightmares, lower anxiety, and improve sleep quality – all crucial factors in managing PTSD symptoms. "Conducting research that reflects the already widespread use of inhaled cannabis is essential to ensuring that providers, consumers, and patients can make informed decisions about medical and adult cannabis use," MAPS stated in their announcement.

The Bigger Picture: Cannabis Research Challenges

The MAPS study represents just one example of how challenging it can be to conduct rigorous research on cannabis, despite growing evidence of its potential therapeutic benefits for various conditions. Cannabis remains classified as a Schedule I controlled substance at the federal level, which by definition means it has "no currently accepted medical use." This classification creates a catch-22: it's difficult to research cannabis because it's classified as having no medical use, but without research, it's hard to definitively prove its medical value. For researchers, this means navigating a complex web of regulations, obtaining special licenses, sourcing study cannabis through limited government-approved channels, and facing additional scrutiny at every step of the research process.

Looking Forward: What's Next for the Study

Now that the study has been cleared to proceed with smoking as the administration method, MAPS can begin setting up clinical sites and preparing for participant recruitment. If they succeed in providing the FDA with the additional information needed about the vaporization device, they hope to add that option before the study begins enrolling participants. The results of this research could have far-reaching implications. If smoked cannabis shows benefit for veterans with PTSD in a controlled clinical trial, it could:

• Provide evidence-based guidance for veterans already using cannabis
• Inform healthcare providers about potential benefits and risks
• Support policy changes regarding medical cannabis access
• Lead to further research on specific cannabis compounds and delivery methods

Hope on the Horizon

For veterans who have tried conventional treatments without success, the MAPS study represents hope – hope that science will either validate what many have experienced anecdotally or provide clear guidance about cannabis's limitations. "MAPS remains committed to paving the way for novel cannabis and psychedelic research," the organization stated, highlighting their dedication to this work despite the regulatory challenges. While the road to completing this research has been long and winding, each step forward brings us closer to understanding whether cannabis can truly help those who have served their country and now battle the invisible wounds of war.*This article is based on information from the Multidisciplinary Association for Psychedelic Studies (MAPS) regarding their Phase 2 study of smoked cannabis for veterans with PTSD. 

Source: MAPS.org