The U.S. Food and Drug Administration (FDA) has approved a significant clinical trial to investigate the efficacy of smoked cannabis in treating post-traumatic stress disorder (PTSD) among veterans. This Phase 2 randomized, placebo-controlled study, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), will involve 320 veterans diagnosed with moderate to severe PTSD.
Study Design and Objectives
Participants will self-administer high-THC dried cannabis flower or a placebo, with dosages adjusted based on individual needs, reflecting real-world consumption patterns. The primary goal is to assess the safety and potential therapeutic benefits of inhaled cannabis for PTSD symptoms, providing critical data to inform patients, healthcare providers, and policymakers.
Regulatory Milestones
The approval follows three years of negotiations between MAPS and the FDA, during which the agency issued five partial clinical hold letters addressing concerns over dosing, delivery methods, and participant selection. In August 2024, MAPS submitted a Formal Dispute Resolution Request, leading to the FDA’s decision to allow the trial to proceed with the proposed protocols.
Funding and Support
The study is funded by Michigan’s Veteran Marijuana Research Grant Program, utilizing state cannabis tax revenue to support FDA-approved clinical trials exploring marijuana’s efficacy in treating veterans’ medical conditions and preventing veteran suicide.
Implications for Veterans and PTSD Treatment
PTSD affects approximately 6% of U.S. adults, with higher prevalence among veterans due to combat exposure. Traditional treatments often fall short, leading many veterans to seek alternative therapies like cannabis. This trial aims to provide empirical evidence on cannabis’s effectiveness and safety for PTSD, potentially influencing future treatment protocols and policies.
Expert Perspectives
Dr. Sue Sisley, principal investigator of the study, emphasized the importance of this research in addressing veterans’ needs: “Our veterans are in dire need of treatments that can ease their challenging symptoms of PTSD.”
Future Outlook
The trial’s outcomes could significantly impact medical cannabis research and policy, especially concerning veterans’ healthcare. Positive results may lead to broader acceptance and integration of cannabis-based treatments for PTSD and other conditions.