Psychedelics Likely to Clear Major Barrier in 2023
It appears that the psychedelic renaissance is one year away from a major victory: removal of a psychedelic substance (MDMA) from political death row (Schedule 1 of the Controlled Substance Act (CSA)).
In the War on Drugs, many psychedelic substances were placed on the CSA’s Schedule 1 in the 1970s, meaning they were regarded to have “no current accepted medical use and a high potential for abuse.” These determinations were political, often flying in the face of the then-current science and medical practices, such as the use of psychedelics to address mental health issues. Regardless how they landed on Schedule 1, the designation was decisive and discussion-ending, banishing psychedelics from the public arena.
Listing on Schedule 1 removed almost all possibilities for federal funding and made any research extremely difficult. Those hurdles forced the entirety of America’s formal medical and scientific communities to turn away from psychedelic research. Listing also targeted psychedelics for aggressive police action. Listing on Schedule 1 was a decisive defeat for the use of psychedelic substances that continues to this day.
A few intrepid souls, however, remained unwilling to accept defeat. In a seemingly sisyphean struggle, the Multidisciplinary Association of Psychedelic Studies (MAPS) has worked for decades to remove one psychedelic substance from Schedule 1, believing that MDMA can help people overcome PTSD. The political implications of the battle are huge: removal of one psychedelic substance from Schedule 1 undercuts the foundational support for keeping other substances on the politically-based list.
Despite the high political stakes, opposition to the MAPS initiative has been pushed back a bit by the human implications of the research: specifically, the human toll of PTSD and the high suicide rates of people—including veterans and first responders—who suffer from PTSD.
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After decades of struggle, MAPS reported findings from a major FDA-phase-3 study that use of MDMA-assisted therapy for treating severe PTSD is effective, safe, and well-tolerated. These findings pave the way for FDA approval. Only one more step (a second phase-3 study) stands in the way of MDMA’s likely removal from Schedule 1.
According to the reported findings, 88% of people treated with MDMA-assisted therapy experienced a clinically significant reduction in PTSD symptoms, with 67% no longer qualifying for a PTSD diagnosis. This is still more remarkable when it is noted that the average study participant had suffered PTSD for 14 years and all participants had previously shown resistance to current treatment methods.
MAPS presses forward with its battle and its top-flight research. If the second phase-3 study replicates the impressive data of the first study, FDA will have little choice but to reschedule MDMA, removing it from the chokehold of Schedule 1, proving that listing on Schedule 1 is not unassailable.