MAPS Successfully Clears Path for Cannabis Research through FDA Formal Dispute

In a historic win for mental health and cannabis research, the Multidisciplinary Association for Psychedelic Studies (MAPS) has cleared significant regulatory hurdles to move forward with its Phase 2 clinical trial, MJP2, which investigates the effects of smoked and vaporized cannabis on post-traumatic stress disorder (PTSD). This milestone comes after years of meticulous effort, multiple rounds of regulatory challenges, and a pivotal Formal Dispute Resolution Request (FDRR) with the FDA’s Division of Psychiatry Products (DPP).

This decision not only allows the study of cannabis under conditions that reflect real-world usage but also sets an important precedent for advancing cannabis and psychedelic research.

The proposed clinical trial, MJP2, was initially submitted in March 2021 and faced persistent scrutiny from the FDA’s Division of Psychiatry Products. Between 2021 and 2023, the FDA issued five Clinical Hold letters citing concerns about the safety of smoked and vaporized cannabis, the inclusion of cannabis-naive participants, and the THC dosage reflecting real-world use. MAPS diligently responded to these concerns, including through a Type A meeting in June 2023 and a Complete Response submission in November 2023. Despite MAPS’ efforts, the FDA maintained its hold.

In August 2024, MAPS escalated the matter through a Formal Dispute Resolution Request (FDRR), appealing to the FDA’s Office of Neuroscience. This appeal was grounded in a comprehensive review of the scientific literature, emphasizing that the study’s parameters did not present “an unreasonable and significant risk” to participants. MAPS further argued the study’s importance in filling critical gaps in the cannabis safety and efficacy literature, particularly as cannabis use becomes increasingly widespread under state legalization frameworks.

The FDA’s eventual clearance of MJP2 is a breakthrough for cannabis research. MAPS has successfully secured approval to study cannabis use in a manner that reflects real-world consumption patterns, including:

This approach mirrors the way individuals with PTSD, particularly veterans, use cannabis in everyday life, making the findings more applicable to real-world contexts.

The trial will focus on 320 veterans with PTSD, funded by a $12.9 million grant from the State of Michigan’s Cannabis Regulatory Agency. The study is designed to evaluate the safety and efficacy of inhaled cannabis, with a particular focus on how it alleviates PTSD symptoms. Importantly, MJP2 aims to provide high-quality data on the risks and benefits of cannabis consumption, addressing an urgent public health need for better understanding cannabis’s impact.

MAPS’ victory is not just a win for cannabis research but a significant step forward for the broader field of alternative mental health therapies. By challenging the FDA’s outdated regulatory frameworks, MAPS has paved the way for other researchers to conduct studies using real-world parameters.

This is not MAPS’ first foray into breaking regulatory ground. Over the past 35 years, the organization has been instrumental in advancing MDMA-assisted therapy for PTSD, setting the stage for a proliferation of psychedelic-assisted therapy trials worldwide. Similarly, the approval of MJP2 demonstrates the potential for cannabis to join psychedelics as a transformative treatment option for mental health conditions.

While MAPS celebrates this hard-fought victory, the organization underscores that the work is far from over. Continued regulatory hurdles, a lack of sufficient research funding, and entrenched stigma around cannabis and psychedelics remain challenges. Nevertheless, MAPS remains committed to conducting rigorous scientific research and advocating for evidence-based reforms.

Through this groundbreaking trial, MAPS hopes to illuminate the potential benefits—and risks—of cannabis for PTSD, contributing to a more informed and compassionate approach to mental health care.

As MAPS moves forward with MJP2, they invite public support to help fund and sustain their pioneering work. Donations and advocacy play a crucial role in breaking down barriers to research and ensuring that groundbreaking studies like this one can continue.

For more information about MJP2 and other MAPS initiatives, visit the MAPS website or explore their recent coverage in major outlets like The New York Times. Together, we can help shape the future of mental health treatment and provide critical data to improve the lives of veterans and others living with PTSD.