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Psychedelic-assisted therapy – supposedly paradigm-shifting research with poor attempts at hypotheses falsifying and questionable ethics

Summary

This paper critically examines recent clinical trials testing MDMA and psilocybin for treating PTSD and depression. While these trials reported promising results, the author identifies serious scientific and ethical problems: participants could tell whether they received the drug or placebo due to its strong effects, researchers and therapists who strongly believed in the treatment may have unconsciously influenced patient responses, and negative side effects may have been downplayed. The author argues that without fixing these problems, the entire field of psychedelic therapy research could lose credibility.

Background

Psychedelic-assisted therapy (PAT) is gaining momentum for treatment-resistant depression and PTSD, with several successful phase II and III trials reported. Australia has permitted prescription of psilocybin and MDMA under special access schemes, while the U.S. FDA recently rejected MDMA-assisted therapy (MDMA-AP) for PTSD approval despite positive trial results from Lykos Therapeutics-funded studies.

Objective

This paper critically examines the scientific rigor and ethical standards of psychedelic-assisted therapy research, particularly the MDMA-AP trials for PTSD. The author analyzes methodological inadequacies in hypothesis falsification and violations of biomedical ethical principles in current PAT research.

Results

Analysis reveals that MDMA’s strong psychotropic effects rendered trials essentially unblinded, with nearly all participants correctly identifying their treatment arm. The ICER report documented concerns about therapist influence on patient reporting, potential suppression of adverse event documentation, and inadequate ethical stringency despite positive psychiatric outcome measures.

Conclusion

PAT research exhibits significant methodological and ethical deficiencies including inadequate blinding, bias from researcher advocacy, potential falsification of data through participant influence, and violations of biomedical ethics principles. The field requires strict conformity to scientific standards including neutral researchers, independent monitoring, dose-response studies, or development of non-hallucinogenic alternatives before therapeutic approval.
  • Published in:EXCLI Journal,
  • Study Type:Critical Review,
  • Source: PMID: 39790558, DOI: 10.17179/excli2024-8023
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