MDMA-Assisted Therapy is bound to become the first psychedelic-assisted therapy approved for mental health treatment.
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This trip is becoming a reality. Altered-state psychedelic experiences will soon become a part of mental health treatment, and MDMA is bound to be the first substance used in this capacity1.
Rick Doblin and MAPS1 have been at it for 37 long years, and now they have just analyzed the final batch of data for their unprecedented and historic FDA approval study, and the results reportedly confirm the very promising findings from the earlier parts of that same study. This means that MDMA-Assisted Therapy is now on its way to being approved for treatment (initially for PTSD).
Due to its unprecedented effect sizes (i.e., how effective the treatment is) and its good safety profile, the FDA granted MDMA-Assisted therapy a rare Breakthrough Therapy2 designation for the treatment of trauma (in 2017). The subsequent research has consistently resulted in the same great treatment outcomes, both in terms of effectiveness and safety3. Now, the final round of data from multiple sites with diverse populations reportedly confirm all the previous results.
I spoke to MAPS and they are not in a position to release or discuss details of their results at this point, as they are in the process of submitting the study for publication to a peer-reviewed academic journal. At the same time, the data is being submitted to the FDA to finalize the application to make MDMA-Assisted Therapy available to those in need.
We will provide you with a detailed analysis of this most recent data once it is published later in 2023.
In the meantime, for an amazing first-hand account of how MDMA-Assisted Therapy works, listen to Lori Tipton’s heartfelt and insightful account of her treatment journey on the Enhanced Therapy Podcast: https://enhancedtherapy.ca/a-personal-account-of-the-healing-power-of-mdma-therapy-with-lori-tipton-enhanced-therapy-podcast-4/. Lori also featured in the Netflix documentary “How to change your mind.”
1 You can support MAPS (Multidisciplinary Association for Psychedelic Studies) at maps.org.
2 No psychedelic-assisted therapy has been approved for regular clinical use by the FDA, Health Canada, or any other regulatory authorities at this point.
3 “Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).” FDA
4 To be clear, despite the great promise, MDMA-Assisted Therapy, like any other therapy, will not help everyone. In fact, there is still a whole lot we need to learn about how this therapy works, what the mechanisms of change are, and what the more subtle risks and benefits are.