Following significant discussions and overcoming numerous regulatory challenges, the U.S. Food and Drug Administration (FDA) has endorsed a Phase 2 clinical trial to investigate the therapeutic potential of smoked medical marijuana for veterans suffering from post-traumatic stress disorder (PTSD). The research is funded by Michigan’s legal cannabis sales tax revenue and represents a partnership between the state and the Multidisciplinary Association for Psychedelic Studies (MAPS).
The aim of this landmark trial is to assess the capacity of high-THC marijuana, consumed via smoking, to alleviate moderate to severe symptoms of PTSD—an ailment for which many American veterans currently employ cannabis. It took MAPS over three years of continuous discussions and settlement of differences with the FDA before gaining the green light for this stage of their investigation.
Journey to Sanction
To address the FDA’s reservations, MAPS revised its study protocol to include solely those participants who have previously used cannabis. Despite the FDA’s skepticism regarding the aspect of self-titration in the research—which allows participants to control their own doses—MAPS retained this element, contending its importance for the mirroring of cannabis consumption in everyday scenarios.
The chief researcher, psychiatrist Sue Sisley, emphasized the desperate demand for solid empirical evidence supporting cannabis as an effective treatment for PTSD, reflecting the countless veterans’ accounts of how smoking cannabis ameliorated their PTSD symptoms more effectively than conventional medications. “There is an acute need for validated research, considering the ongoing public health crisis of veteran suicides,” Sisley noted.
While the FDA has consented to the advancement of the study with smoked cannabis at potency levels available in commerce, it has placed an interim restriction on experimenting with vaporization techniques, pending a review of the safety of specific apparatuses.
Financing Innovative Studies
For the purposes of FDA-sanctioned, nonprofit-led clinical trials that delve into the potential of marijuana in the healing of veteran ailments and the prevention of suicide, the Michigan Veteran Marijuana Research Grant Program, utilizing tax revenue from lawful cannabis sales, has apportioned $13 million in 2021, adding up to a funding cycle of $20 million.
As this trailblazing trial proceeds, its findings are poised to shape future cannabis policies and therapeutic practices. With the victory of attaining approval for research now achieved, medical practitioners, veterans, and campaigners are eagerly anticipating the results, hopeful for the emergence of novel treatments aimed at mitigating PTSD.
The FDA approves the clinical trial of smoked marijuana, foreseeing its application in PTSD treatment for veterans. This promising study is set to shine a light on alternative therapies, potentially providing crucial insights into new strategies to treat those who have served..
