In medical research, a double-blinded placebo controlled trial-in which neither the participants nor the researchers know who gets a placebo or the experimental treatment-is considered the gold standard. But the effects of psychedelics are so well known that it's easy for volunteers and therapists alike to guess whether they received it.
My main concern is that people in the trial who did not receive the MDMA would experience a lot of disappointment about not getting the drug, and that would have a large influence on how they reported their symptoms.
This 'unblinding' effect is a well-known conundrum not just for Lykos but for the entire field of psychedelics research, and scientists are currently considering alternative ways of designing trials to account for this potential bias.
FDA committee members had concerns with the variability in therapy approaches and how much of patient outcomes could be attributed to the drug.
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