In 2021, federal health officials rejected a clinical trial proposal aimed at evaluating the safety and efficacy of marijuana for treating military veterans with post-traumatic stress disorder (PTSD). The Food and Drug Administration (FDA) expressed concerns that allowing patients to smoke high-potency marijuana posed an unjustifiable health risk and objected to the idea of patients consuming cannabis as needed to alleviate symptoms.
However, this month, the FDA unexpectedly authorized the trial to proceed, marking a rare instance where the agency has permitted the use of marijuana in a study focused on its therapeutic benefits rather than its harms. An FDA spokeswoman noted that the agency recognizes the need for additional treatment options for mental health conditions like PTSD.
Historically, the federal government has prioritized research on the negative effects of marijuana. However, the legalization of cannabis in various states has provided funding for studies exploring its therapeutic potential. Experts have pointed out a significant gap in understanding the substance, which is widely used both therapeutically and recreationally.
Public support for marijuana legalization has increased, with many states establishing medical marijuana programs and legalizing recreational use. Although recent efforts to legalize recreational marijuana in three states were unsuccessful, Nebraska became the 39th state to legalize medical marijuana. Currently, 24 states and the District of Columbia allow recreational use.
The Biden administration proposed downgrading cannabis from Schedule I, the most restrictive drug category, although the timeline for any changes remains uncertain. This classification has historically created significant barriers to research and development related to marijuana.
Experts suggest that the incoming administration may also support a more permissive approach to cannabis regulation. Recent challenges in obtaining approval for marijuana studies have left researchers reliant on low-potency cannabis from a federally sanctioned lab, which has faced criticism.
The Department of Health and Human Services acknowledged the barriers to conducting marijuana studies in a report to Congress, emphasizing the need for rigorous research to understand cannabis's therapeutic potential and associated risks. The new study, funded by a $12.9 million grant, will utilize commercially available high-THC marijuana from Canada and aims to enroll approximately 320 military veterans.
Previous studies, such as one conducted in 2018 with only 76 participants, did not find marijuana more effective than a placebo for reducing PTSD symptoms. Researchers believe that the larger sample size and higher potency of the new study will yield clearer insights into cannabis's effects on PTSD.
While some experts express concerns about the ethical implications of allowing participants to smoke marijuana, researchers argue that smoking is the most common method of use and provides immediate effects, which is crucial for PTSD patients. The FDA's recent decision was unexpected, especially following its earlier rejection of a proposal to approve MDMA as a PTSD treatment.
As medical cannabis becomes more accessible, its use for various conditions has increased, although leading medical organizations have raised concerns about its efficacy for mental health issues. The American Psychiatric Association has warned that there is no scientific evidence supporting cannabis's effectiveness in treating psychiatric disorders and cautioned about its potential for addiction.
Despite the Department of Veterans Affairs encouraging discussions about cannabis use among veterans, it prohibits clinicians from recommending medical marijuana cards, a stance that has frustrated veteran advocacy groups. Some veterans, like Gary Hess, have reported significant benefits from using cannabis to manage PTSD symptoms.
While some researchers welcome the FDA's more open stance on medical cannabis studies, others remain skeptical about its effectiveness for PTSD treatment based on existing research. Nonetheless, there is a growing consensus on the need to explore all potential interventions, including cannabis, for which the benefits may outweigh the risks.