MAPS' Phase 3 Trial for MDMA-Assisted Therapy in PTSD is now published
In last week's newsletter, we shared the exciting news that the first Phase 3 trial conducted on psychedelic-assisted therapy has successfully shown the merits of MDMA-Assisted Therapy for PTSD. This trial was sponsored and financed by MAPS, and paves the way for FDA approval as early as 2023. The full paper is now published in Nature Medicine.
The authors say that “unlike traditional pharmaceuticals, MDMA does not act as a band-aid that tries to blunt symptoms of PTSD. Instead, in people with PTSD, MDMA combined with therapy seems to allow the brain to process painful memories and heal itself”.
Key Study Takeaways:
- The highly statistically significant results and excellent safety record suggest MDMA-assisted therapy will be an effective treatment for severe, chronic PTSD
- 67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis and 88% experienced a clinically meaningful reduction in symptoms
- The pivotal Phase 3 trial treated 90 patients with severe, chronic PTSD from any cause with an average duration of 14 years and replicated the results of Phase 2 trials
- Study participants included patients with PTSD caused by combat-related events; accidents; abuse; and sexual harm; 84% have a history of developmental trauma
- MAPS is hopeful that these results will facilitate FDA approval in 2023 for this Breakthrough-designated therapy
You can also read the about the findings in an article published by the New York Times.
For more updates on the latest psychedelic news and research, visit the psychedelic health professional network homepage.