Studying harms Is key to improving psychedelic-assisted therapy— Participants call for changes to research landscape

The authors of this JAMA Psychiatry article write: "Although psychedelic drugs generally have good safety profiles, a recent systematic review concluded that adverse events in psychedelic trials are poorly defined, not systematically assessed, and likely underreported. In the past year there have been multiple reports of serious adverse events (SAEs), and long-lasting harms to participants in clinical trials of psychedelic-assisted therapy (PAT) have emerged. We draw attention to a unique and overlooked category of risk in PAT stemming from the interactions between therapists and patients receiving high doses of psychedelics. In our view, the understudied therapeutic component of PAT presents the most serious risks. Addressing it requires interdisciplinary approaches by researchers free from conflicts of interests … Research participants who have experienced harm in psychedelic clinical trials, two of whom are authors of this Viewpoint, have a unique epistemic standpoint from which to improve the field. We point to the psychotherapy protocols that accompany psychedelic administration as an understudied and undertheorized source of preventable risk in PAT. If the field fails to attend to this gap, anticipated regulatory approvals will mandate that patients undergo untested and controversial psychotherapy protocols alongside the use of psychedelics. This would expose future patients to unnecessary risk and put clinicians at risk of malpractice if the SAEs reported herein were to occur in their clinical practices. To avert this possibility, researchers must undertake phenomenological research to better understand SAEs, and researchers without personal and financial conflicts of interest must conduct and evaluate research."

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