In a big step towards the legalization of MDMA-Assisted Therapy, Nature Medicine just published the results from the final study required by the FDA before the culmination of the MDMA-AT approval process.
We are witnessing history in the making. The eesults of this study are consistent with all previous research, showing that MDMA-AT is not only very effective for the treatment of PTSD but also safe. This opens the door for MAPS to put forward an application with the FDA to make MDMA-AT available for medical use. If successful, the US DEA (Drug Enforcement Administration) will then reschedule MDMA to make it available for medical use. Health Canada is then likely to approve MDMA-Assisted Therapy as well. Of course all this is speculation at this point, and MDMA remains illegal in both Canada and the USA, and MDMA-Assisted Therapy is still available only in very limited contexts.
But back to this historic study. Here are some key takeaways:
· MDMA appears to be safe and effective across a broad cross-section of age, gender, and race. No surprises here!
· The MDMA dosages used were the same as before: 80-120 mg with a supplementary dose of 40-60. Note that proper dosages are very important in MDMA-Assisted Therapy for reasons of both optimal effectiveness and safety.
· 71% of participants no longer met the diagnosis for PTSD after MDMA-AT treatment. This compares to 48% of participants who received psychotherapy only. As before this is a very significant result, especially since PTSD is difficult to treat. Notably, half of the participants in a non-MDMA therapy also improved significantly, which means that regular therapy can also be quite effective for PTSD, as we already know from research using modalities such as Prolonged Exposure, EMDR, Cognitive Processing Therapy, and so on.
· For stats geeks, the effect sizes (how much of a difference the therapy made) were (if I understand correctly) slightly smaller than in the previous study, ranging from d=.4 to d=.7 (meaning “moderately large” effects) when compared between the MDMA-AT and non-MDMA Therapy groups. To be clear, this is still a very significant difference, and if MDMA-Assisted Therapy was compared to no therapy at all (as is often done with other therapeutic modalities), this effect size would still likely be very impressive and fair quite well when compared to other established therapeutic modalities for PTSD (of course in order to properly compare different therapeutic modalities, research would have to actually directly compare different modalities while controlling for other variables). The bottom line: this therapy works, and works well.
· No serious adverse effects were observed. Great!
· Cardiac function was especially attended to. Predictable increases in heart-rate and blood pressure were observed, with no need for any interventions (sympathomimetic effect of MDMA).
· Suicidal ideation was also closely attended to. Suicidality was predictably observed in many traumatized individuals, but MDMA did not seem to contribute to an increase in suicidality. So that’s good news as well!
I think that’s it for now. One part of me wants to say, welcome to the revolution in mental health treatment! While another part of me says, let’s take this very slowly and cautiously, allow the scientific evidence to accumulate, and make every effort to learn how to deliver these potentially-promising therapies in the safest and most effective way.
The full publication @ https://www.nature.com/articles/s41591-023-02565-4