Last month, MAPS Public Benefit Corporation or MAPS PBC published results from the second half of their Phase 3 study. This highly anticipated research looked into whether MDMA-assisted therapy, compared with placebo, is a safe and effective way to treat moderate and severe post-traumatic stress disorder or PTSD.
MAPS PBC is a subsidiary of MAPS or the Multidisciplinary Association for Psychedelic Studies, a non-profit organization founded by Rick Doblin PhD in 1986 as a legitimate way to continue scientific research into psychedelics and marijuana, despite the US government’s failed drug policies. Because the goals of MAPS and the study are so closely aligned, Jennifer Mitchell PhD and the study’s other researchers designed a costly but rigorous trial that would stand up to outside scrutiny—aka good science. Beyond its multi-site, randomized, double-blind controls, the research studied a relatively large, afflicted, and diverse group of participants over 18 weeks or nearly five months:
Many have reported that if approved, MDMA-assisted therapy (MDMA-AT) would be the first new PTSD intervention in over 20 years. Let that sink in. MAPS PBC states that PTSD affects 13 million or nearly 4% of all Americans each year with debilitating symptoms which bring about a negative economic impact of over $200 billion annually. And in the last twenty years, our government has not approved any new treatments, until possibly now.
Notably, 45 of 52 or 86.5% of the participants who were treated with MDMA-assisted therapy achieved a clinically meaningful benefit. And 37 of the same 52 or 71.2% no longer met the criteria for PTSD by the study's end.
All medicines and therapies, especially psychedelic-assisted therapies like the one studied, should prove reasonably safe and effective before widespread adoption. How can we, with all our hopes, biases, and incentives (political and financial) ever actually prove something? Statistics. That the mean MDMA-AT score was 8.9-points* lower than the mean placebo score was impressive. However, its p-value of <0.001 appears conclusive. In other words, the study found that there is at least a 99.999% chance that the average reduction in PTSD symptoms is greater with MDMA-AT than placebo.
* The mean CAPS-5 total severity score from baseline to 18-weeks was a reduction of 23.7 for MDMA-AT vs 14.8 for placebo
Also noteworthy was the study’s conclusion that MDMA-AT appears to be very safe. Not only were the adverse events, “mostly transient and mild or moderate in severity,” no major safety issues were reported. Recall that MDMA is an amphetamine but did not appear to result in any negative outcomes related to cardiac function, suicide, or abuse, misuse, or diversion in this study. This is despite some of the participants having histories of moderate alcohol and substance-use disorders.
Completing Phase 3 was a major milestone for MDMA-AT, psychedelics, and the field of mental health. However, despite the strong indications that this approach will be valuable for society, there is still uncertainty. MAPS PBC now plans to submit a New Drug Application to the US Food and Drug Administration or FDA but there remain tough open questions.
At Innerbloom Ketamine Therapy, we are keeping a close eye on progress related to psychedelic-assisted therapy such as studies like this and regulatory developments like SB58 which Governor Newsom recently vetoed. (Two steps forward, one step back?) And while we may offer these treatments in the future once they become better understood, more widespread, and legal, for now we are focused on ketamine therapy.
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