7% PTSD trial participants reported increased suicidality with MDMA treatment

  • SOURCE ▸
    PUBLISHED
  • March 29, 2023
  • AUTHORS
  • Sarah McNamee, MSW, MScA; Neşe Devenot, PhD; Meaghan Buisson, BSc
  • PUBLICATION
  • JAMA Psychiatry
  • TITLE
  • 7% PTSD trial participants reported increased suicidality with MDMA treatment
  • Studying Harms Is Key to Improving Psychedelic-Assisted Therapy—Participants Call for Changes to Research Landscape
  • KEY TAKEAWAY
  • In a phase 3 trial of MDMA for PTSD, 7% of participants reported increased feelings of suicidality, underscoring the need for careful monitoring and support during treatment.

Psychedelic-assisted therapy (PAT) has gained attention for its potential in treating various mental health conditions, underlined by generally favorable safety profiles. However, concerns about the assessment and reporting of adverse events in PAT trials indicate a need for a more rigorous scrutiny of its risks. A systematic review highlighted that adverse events in psychedelic trials are not only poorly defined but also not systematically assessed and are likely underreported. Moreover, the past year has seen multiple reports of serious adverse events (SAEs) and long-lasting harms to participants in PAT trials.One particularly underexplored area of risk in PAT is the dynamic between therapists and patients, especially considering the high doses of psychedelics involved. This interaction, crucial to the therapeutic process, may present significant risks that have not been adequately studied. Addressing these risks necessitates an interdisciplinary approach by researchers who are not influenced by conflicts of interest.The recognition of these concerns calls for a shift in the research landscape surrounding PAT. Specifically, it underscores the importance of developing more precise definitions and systematic assessments of adverse events. Additionally, the call for transparency and thorough reporting is paramount to fully understand and mitigate the risks associated with PAT. The aim should not only be to enhance the safety and effectiveness of PAT but also to ensure that participants in clinical trials are protected from potential long-lasting harms.In conclusion, while PAT offers promising therapeutic benefits, a critical evaluation of its risks, especially those arising from the therapist-patient interactions under the influence of psychedelics, is crucial. Interdisciplinary research efforts free from conflicts of interest are essential to improve our understanding of these risks, ultimately leading to safer and more effective therapeutic practices.

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