The U.S. Food and Drug Administration (FDA) has greenlit a clinical trial to investigate the effectiveness of medical cannabis in treating post-traumatic stress disorder (PTSD) among military veterans. This decision comes after a three-year dispute and multiple rejections, marking a significant milestone for cannabis research and its potential therapeutic applications.
MJP2: A Landmark Study
The study, formally known as MJP2, is a phase II clinical trial led by the Multidisciplinary Association for Psychedelic Studies (MAPS). It will involve 320 veterans with PTSD who have prior experience smoking or vaping cannabis. The trial is supported by a $12.9 million grant from the Michigan Veteran Marijuana Research Grant Program and the state Cannabis Regulatory Agency.
Dr. Allison Coker, director of cannabis research at MAPS, emphasized the importance of the study, stating, "Despite the increasingly widespread use and acceptance of cannabis in patients with PTSD... there is still a lack of high-quality, controlled data on the safety and effectiveness of cannabis use that reflects real-world consumption patterns."
MJP2 is designed to bridge this evidence gap by studying the 'real-world' use of inhaled cannabis to understand its potential benefits and risks in treating PTSD.
Addressing Regulatory Hurdles
The FDA's approval was not without its challenges. The agency initially raised concerns about the study's design, including the proposed dosage, delivery method, and inclusion of cannabis-naïve participants. MAPS addressed these concerns through persistent advocacy and a formal dispute resolution request, ultimately leading to the FDA's approval with modifications to the study protocol.
Real-World Cannabis Use
A key aspect of MJP2 is its focus on replicating real-world cannabis use. Participants will self-titrate their daily doses of high-THC cannabis flower, mirroring how veterans typically use cannabis to manage their PTSD symptoms. This approach aims to provide more relevant and applicable data compared to studies using standardized doses or alternative delivery methods.
The Urgent Need for New Treatments
The study holds particular significance for veterans, who experience disproportionately high rates of PTSD and suicide. Traditional treatments are often insufficient, leading many veterans to seek relief through cannabis. Dr. Sue Sisley, a principal investigator for MJP2, noted that many veterans in her practice have reported that smoking cannabis provides more relief than traditional pharmaceuticals.
"Veterans are in dire need of treatments that can ease their challenging symptoms of PTSD," said Dr. Sisley. "This study will generate the high-quality data we need to develop evidence-based treatment plans."
Implications for Future Research
The FDA's approval of MJP2 signals a potential shift in the agency's approach to cannabis research. It reflects a growing recognition of the need for more data on the safety and efficacy of cannabis for various medical conditions. The results of MJP2 could pave the way for future cannabis research and inform the development of evidence-based treatment guidelines for PTSD and other conditions.
