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The Case for MDMA's Approval Is Riddled With Problems
Jun 10, 2024
Debating MDMA's Approval for PTSD Treatment: FDA evaluating MDMA for PTSD, issues with trial data, concerns about therapy standardization, participant bias, and ongoing debate around effectiveness and ethics of this approach
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Quick takeaways
- MDMA-assisted therapy for PTSD shows potential in reducing symptoms and no longer meeting PTSD criteria.
- Challenges in clinical trials include unblinding effects, therapy standardization issues, and ethical concerns about therapist behavior.
Deep dives
Mixed FDA Committee Votes on MDMA for PTSD Treatment
The FDA advisory committee deliberated on the effectiveness of MDMA alongside psychotherapy for PTSD treatment. While the committee mostly cited insufficient evidence to support its approval, trial results showed promising outcomes with some participants no longer meeting PTSD criteria after therapy with MDMA. Concerns included participants potentially knowing if they received the drug or placebo, variability in therapy approaches, and unaddressed data on liver function and post-trial MDMA abuse.
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