The FDA has granted approval for a Phase 2 clinical trial to investigate the efficacy of smoked marijuana in treating post-traumatic stress disorder (PTSD) among military veterans. This landmark study, funded by cannabis sales tax revenue from Michigan, marks a significant step forward in cannabis research and its potential use in mental health treatment.
The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the FDA's approval for a randomized, placebo-controlled trial involving 320 veterans diagnosed with moderate to severe PTSD who have prior experience using cannabis. Participants will self-titrate their daily dose of high-THC dried cannabis flower versus a placebo, mimicking real-world consumption patterns.
Addressing a Critical Need
Sue Sisley, the principal investigator for the study, emphasized the importance of this research, stating, "Within the United States, millions of Americans are smoking or vaporizing cannabis to manage or treat their symptoms. In the absence of high-quality data related to cannabis, much of the information available to patients and regulators is rooted in prohibition and focused only on potential risks, without consideration of potential benefits."
PTSD affects an estimated 11-20% of veterans who served in Operations Iraqi Freedom and Enduring Freedom, 12% of Gulf War veterans, and 30% of Vietnam War veterans, according to the U.S. Department of Veterans Affairs. Current treatments, including traditional pharmaceuticals, often fall short in providing adequate relief, leading many veterans to seek alternative therapies like cannabis.
Overcoming Regulatory Hurdles
The approval follows three years of negotiations with the FDA, during which MAPS addressed five partial clinical hold letters. Key issues included the proposed THC dose, smoking as a delivery method, and the enrollment of cannabis-naive participants. MAPS ultimately updated the protocol to require participants to have prior experience inhaling cannabis and maintained the study design allowing for self-titration.
Allison Coker, director of cannabis research at MAPS, noted that the FDA allowed Phase 2 to proceed with smoked cannabis at commercially available THC levels. However, vaporization remains on hold pending further safety assessments.
Study Design and Objectives
The trial is designed to reflect the "real-world" use of inhaled cannabis, aiming to understand its potential benefits and risks in treating PTSD. The primary objective is to evaluate the efficacy of smoked cannabis in reducing PTSD symptoms compared to placebo. Secondary endpoints may include assessing the impact on sleep quality, anxiety levels, and overall quality of life.
Rick Doblin, founder and president of MAPS, stated, "Veterans are in dire need of treatments that can ease their challenging symptoms of PTSD. MAPS takes pride in leading the way to open new research pathways by challenging the FDA to think differently."
The study is funded by Michigan’s Veteran Marijuana Research Grant Program, which allocates state revenue from legal cannabis taxes to support FDA-approved clinical trials researching the efficacy of marijuana in treating medical conditions of U.S. armed services veterans and preventing veteran suicide.
