The FDA has granted a rare approval for a study investigating the therapeutic effects of cannabis on veterans suffering from post-traumatic stress disorder (PTSD). This decision could pave the way for new treatment options for a condition affecting a significant portion of the veteran population.
The study, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), will involve 320 veterans with moderate to severe PTSD. It is funded by the Michigan Veteran Marijuana Research Grant Program with roughly $13 million.
Study Design and Objectives
The research will examine the impact of inhaled high-THC dried cannabis flower compared to a placebo. Participants will self-titrate their daily dose. The study design addresses the need for controlled data on cannabis use, reflecting real-world 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."
Overcoming Regulatory Hurdles
Securing FDA approval for this study was a lengthy process. MAPS faced five partial clinical hold letters from the FDA over three years. Objections related to the proposed THC dose, delivery methods (smoking and vaping), and participant knowledge of cannabis. A formal dispute-resolution request was submitted in 2023, leading to an agreement to study only veterans with prior cannabis experience.
The Need for Alternative PTSD Treatments
Approximately 7% of veterans experience PTSD, translating to about 1.1 million individuals out of the 15.8 million veterans in the U.S., according to the U.S. Department of Veterans Affairs. The FDA acknowledges the "great need for additional treatment options" for PTSD.
Sue Sisley, the study's principal investigator, noted, "Our veterans are in dire need of treatments that can ease their challenging symptoms of PTSD... In my own practice, veteran patients have shared how smoking cannabis helped them manage their PTSD symptoms more than traditional pharmaceuticals."
Potential Impact on the Cannabis Sector
While the commercialization of any resulting drug treatments is years away, a favorable study outcome could boost the cannabis sector. Conversely, a study showing no benefit could hinder the sector's growth. The AdvisorShares Pure U.S. Cannabis ETF MSOS, an exchange-traded fund of U.S. cannabis stocks, is down 34.8% so far in 2024.
Differing Perspectives
Not all medical professionals are convinced of cannabis's effectiveness for PTSD. Harold Kudler, an associate professor of psychiatry at Duke University, expressed doubts based on past studies but supports further research. He stated he couldn't "in good conscience recommend it to anybody because I'd feel I was doing more harm than good."
Federal Cannabis Policy
Cannabis is currently classified as a Schedule I drug under federal law, alongside heroin and LSD. However, there are signs of a potential shift in federal policy. The Biden administration has proposed moving cannabis to Schedule III, a less restrictive classification. The Drug Enforcement Administration (DEA) is planning a hearing on the proposal next year.
Currently, 25 states have legalized cannabis for recreational use, and 38 states have medical-use programs.
