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MDMA-Assisted Therapy Passes Another Big Milestone

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.

While I strongly encourage anyone interested in the future of mental health treatment to read the press release and research paper in Nature Medicine, I summarized a few of my own insights below.

The study was well controlled for the real world.

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:

  • 104 participants who suffered moderate to severe PTSD for an average of 16 years,
  • 71.2% assigned female sex at birth, and
  • 33.7% identified as non-white.

The findings are a significant development.

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.

The results are powerful.

Female friend or family sitting and hold hands during cheer up to mental depress man, Psychologist provides mental aid to patient.

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

The treatment appears safe.

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.

There is more work to be done.

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.

  • Will mental health practitioners adopt or resist these new forms of psychedelic-assisted therapy?
  • How will other US federal agencies like the Drug Enforcement Agency or DEA and state governments support or block change? (The current US Congress, with its 535 members, only 19 or 3.6% of which are physicians, still believes that MDMA has no currently accepted medical use and a high potential for abuse and is therefore a Schedule 1 controlled substance.)
  • What specifically will the FDA approve? It has never approved a drug-assisted therapy and it’s unclear whether it has the jurisdiction to do so.
  • Assuming any approval is contingent on therapist-led treatment, what types of therapist training and licensing may be needed? How much will this cost and how will access to MDMA-AT be equitable?

Concluding Remarks

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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