The FDA has greenlit a study to assess the therapeutic potential of cannabis in treating post-traumatic stress disorder (PTSD) among veterans, a move that could have implications for the cannabis industry. The study, involving 320 veterans, aims to provide much-needed data on the safety and efficacy of cannabis use for PTSD, a condition affecting a significant portion of the veteran population.
Study Details and Objectives
The Multidisciplinary Association for Psychedelic Studies (MAPS) is sponsoring the $13 million trial, funded by the Michigan Veteran Marijuana Research Grant Program. The study will investigate the effects of inhaled high-THC dried cannabis flower compared to a placebo, with participants determining their own daily dosage. This approach seeks to mirror real-world cannabis consumption patterns among PTSD patients.
Allison Coker, director of cannabis research at MAPS, emphasized the importance of this research, 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."
Overcoming Regulatory Hurdles
Securing FDA approval for this study was a lengthy process, with MAPS facing five partial clinical hold letters from the agency over three years. Objections related to the proposed THC dose, delivery methods (smoking and vaping), and participant selection. MAPS addressed these concerns by agreeing to include only veterans with prior cannabis experience.
Perspectives on Cannabis and PTSD
Sue Sisley, the study's principal investigator, highlighted the urgent need for effective PTSD treatments for veterans. "Our veterans are in dire need of treatments that can ease their challenging symptoms of PTSD," Sisley said. "In my own practice, veteran patients have shared how smoking cannabis helped them manage their PTSD symptoms more than traditional pharmaceuticals."
However, not all experts are convinced of cannabis's effectiveness for PTSD. Harold Kudler, an associate professor of psychiatry at Duke University, expressed skepticism based on past studies but supports further research in the area.
Potential Impact on the Cannabis Industry
The study's outcome could significantly influence the cannabis sector. Positive results might pave the way for wider cannabis use in PTSD treatment, potentially boosting cannabis stocks. Conversely, negative findings could impede the sector's progress. Any impact, however, is likely years away due to the extensive drug commercialization process.
Broader Context of Cannabis Regulation
The FDA's decision to approve this study comes amid ongoing debates about cannabis legalization and rescheduling at the federal level. While cannabis remains classified as a Schedule I drug under federal law, there are signs of a potential shift in policy, including the Biden administration's proposal to move cannabis to Schedule III.
