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Psychedelic Therapy Frontiers
The psychedelic renaissance is here! Join Dr. Steve Thayer, Dr. Reid Robison, and special guests as they explore the frontiers of psychedelic medicine and what it takes to cultivate a healthy mind, body, and spirit. Our hosts draw from their extensive knowledge and experience with psychedelic therapy research and treatment to discuss the science, practice, and art of psychedelic healing. If you are a helping professional, therapist, clinician, guide, healer, psychedelic enthusiast, or simply curious about mental, physical, and spiritual health, this is the podcast for you!
Psychedelic Therapy Frontiers
FDA Advisory Committee votes ‘No’ on MAPS/Lykos MDMA-assisted therapy approval
In today’s episode of the Psychedelic Therapy Frontiers podcast Dr. Steve Thayer and Dr. Reid Robison talk about the recent FDA psychopharmacologic drugs advisory committee meeting that resulted in a majority vote against the approval of MDMA-assisted therapy for PTSD based on MAPS/Lykos study data. They discuss what the committee’s concerns were, the Institute for Clinical and Economic Review’s (ICER) criticisms of the studies, the challenges of conducting psychedelic clinical trials, functional unblinding, how research and rater bias affects study data, and much more.
https://psychedelicalpha.com/news/exclusive-therapists-and-trialists-from-lykos-phase-3-mdma-assisted-therapy-studies-push-back-on-icers-critical-draft-report
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