Enhancing Methodological Rigor in Controlled Trials of Psychedelics

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For a deep look into how to conduct scientifically rigorous psychedelic clinical trials, read our team’s featured article in the September 2022, Volume 4, Issue 3 of The Journal of Psychedelic Psychiatry, titled “Enhancing Methodological Rigor in Controlled Trials of Psychedelics.”

Abstract: There has recently been a resurgence in the clinical development of pharmacologic treatments for psychiatric disorders, exemplified by a renewal of psychedelic research. Given the unmet need for new therapies in psychiatry and encouraging positive results from initial psychedelic clinical trials, there is tremendous enthusiasm and promotion of their potential for a variety of indications. Though promising, this enthusiasm has been ahead of a general acceptance of rigorous clinical trial methodology and optimization of study designs to show treatment effects and sufficient characterization of safety. Importantly, although psychedelics are largely considered to have a favorable safety profile, their pharmacology is complex, and their use is not without risk. Only recently have clinical trials in major depression, treatment-resistant depression, post-traumatic stress disorder, and other indications been undertaken in efforts to replicate earlier proof-of-concept trials. These well-controlled clinical trials in larger patient samples are needed to further characterize which patients might be predisposed to adverse reactions, which patient characteristics might predict response, and the optimal treatment setting. This paper outlines the need for conducting psychedelic clinical trials with more rigor, not only to substantiate efficacy but also to characterize their safety.

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