The nascent cannabis research field recently hit a major milestone after the U.S. Food & Drug Administration (FDA) finally greenlit Phase 2 of the Multidisciplinary Association for Psychedelic Studies (MAPS) study on the feasibility of using smoked cannabis to treat post-traumatic stress disorder (PTSD) in veterans.
The authorization came after three years of discussion between the FDA and MAPS. Titled MJP2, the study will test the efficacy and safety of inhaling high-THC cannabis in managing PTSD symptoms in veterans compared to a placebo. Nearly 320 veterans from Michigan and three additional states will take part in the study.
The Michigan Veteran Marijuana Research Grant Program, which draws its funding from state marijuana tax revenue, will provide a $12.9 million grant for Phase 2 of the smoked cannabis study.
Although medical cannabis was first legalized in the U.S. well over two decades ago, the drug’s controlled status at the federal level has made it virtually impossible for researchers to study cannabis. However, now that dozens of states have legalized either recreational or medical marijuana and tens of millions of Americans have access to the drug, there is a pressing need for concrete data on the potential risks and benefits of cannabis.
Past studies have already found evidence that marijuana can mitigate some of the symptoms of physical conditions such as epilepsy or chronic pain but many physicians are reluctant to consider cannabis as an alternative treatment to psychological conditions.
The American Psychiatric Association (APA) even published two statements in 2019 stressing against the use of cannabis to treat psychological conditions. The APA specifically cited PTSD as a psychological condition that shouldn’t be treated with cannabis, noting that there simply weren’t enough credible studies that showed its effectiveness against the condition, and said further research would be required to determine if marijuana affects psychological disorders.
Consequently, the FDA’s decision to green light MJP2 is a major step for cannabis research in the U.S. The Phase 2 study reflects how average users typically consume cannabis by using smoking and vaping as the main delivery agents as well as high THC cannabis that’s similar to the product sold in cannabis establishments.
The FDA pushed back against study protocols such as letting study participants self-titrate or determine their cannabis doses, allowing vaping on a preliminary basis, and preventing the researchers from including individuals who had never smoked cannabis in the study. Despite the limitations MAPS researchers are facing, the fact that the study received FDA approval for a second Phase is a major step in the right direction.
Marijuana industry actors, such as Curaleaf Holdings Inc. (CSE: CURA) (OTCQX: CURLF), will be watching to see what findings this landmark study releases and how that could affect the future of marijuana research.
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