The Carlat Psychiatry Podcast cover image

The Carlat Psychiatry Podcast

MDMA: What Went Wrong Part 2

Jun 17, 2024
Psychiatrist Chris Aiken and PMHNP Kellie Newsome discuss the recent FDA rejection of MDMA therapy for PTSD, exploring issues like boundary violations and functional unblinding. They analyze biases in medication trials, potential risks of MDMA, and the advocacy for its medical use in treating PTSD. The podcast also explores cardiovascular risks of MDMA, therapist influence on patient outcomes, and the need for standardized evaluation methods.
26:59

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Quick takeaways

  • MDMA-assisted therapy faced FDA rejection due to concerns over boundary violations and functional unblinding.
  • Challenges in assessing efficacy and biases hindered the approval of MDMA for PTSD therapy.

Deep dives

MDMA-Assisted Therapy Rejected by FDA Panel

The FDA panel voted against approving MDMA-assisted psychotherapy for PTSD, citing concerns such as sexual boundary violations and functional unblinding. Despite a chance for approval, a majority of panel members were against it, with worries about potential biases affecting patient experiences and reporting of symptoms.

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