The FDA has granted approval for a Phase 2 clinical trial evaluating the use of inhaled cannabis for the treatment of post-traumatic stress disorder (PTSD) in veterans. This decision comes after a three-year hold and marks a significant step forward in exploring alternative treatments for this debilitating condition.
The trial, known as MJP2, is sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and supported by a $12.9 million grant from the Michigan Veteran Marijuana Research Grant Program. MJP2 will assess the safety and efficacy of inhaled high-THC cannabis flower compared to a placebo in 320 veterans diagnosed with moderate-to-severe PTSD who have prior experience using cannabis.
A key aspect of the trial design is the ability for participants to self-titrate their dosage, allowing them to select a THC potency that mirrors what is available in legalized states. This approach aims to reflect real-world cannabis use and provide more ecologically valid data.
Previous Research and FDA Concerns
The MJP2 trial builds upon the findings of its predecessor, MJP1, which suggested that inhaled cannabis (high THC, high cannabidiol, and a combination of both) improved PTSD symptoms such as anxiety, depression, and sleep quality in 76 veterans with chronic PTSD. However, despite these promising early results, the FDA placed MJP2 on hold in 2021 due to safety concerns related to inhaled, high-THC cannabis and the self-dosing methodology.
The FDA's concerns also extended to the use of vaporization as a delivery method. However, following a Formal Dispute Resolution Request (FDRR) and continued engagement from MAPS, the agency has resolved these issues and no longer objects to vaporization, pending additional safety assessments of the device.
Implications and Perspectives
Rick Doblin, Ph.D., founder and president of MAPS, emphasized the importance of challenging conventional approaches to drug research. "MAPS refused to compromise the study design in order to fit into the standard box of FDA thinking in order to ensure that cannabis research reflects cannabis use."
Sue Sisley, M.D., the study’s Principal Investigator, highlighted the potential impact of the research on clinical practice. "MJP2 will generate data that doctors, like myself, can use to develop treatment plans to help people manage their PTSD symptoms."
