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Review
. 2023 Sep 25:13:20451253231198466.
doi: 10.1177/20451253231198466. eCollection 2023.

History repeating: guidelines to address common problems in psychedelic science

Michiel van Elk  1 , Eiko I Fried  2
Affiliations
Review

History repeating: guidelines to address common problems in psychedelic science

Michiel van Elk et al. Ther Adv Psychopharmacol. .

Erratum in

Abstract

Research in the last decade has expressed considerable optimism about the clinical potential of psychedelics for the treatment of mental disorders. This optimism is reflected in an increase in research papers, investments by pharmaceutical companies, patents, media coverage, as well as political and legislative changes. However, psychedelic science is facing serious challenges that threaten the validity of core findings and raise doubt regarding clinical efficacy and safety. In this paper, we introduce the 10 most pressing challenges, grouped into easy, moderate, and hard problems. We show how these problems threaten internal validity (treatment effects are due to factors unrelated to the treatment), external validity (lack of generalizability), construct validity (unclear working mechanism), or statistical conclusion validity (conclusions do not follow from the data and methods). These problems tend to co-occur in psychedelic studies, limiting conclusions that can be drawn about the safety and efficacy of psychedelic therapy. We provide a roadmap for tackling these challenges and share a checklist that researchers, journalists, funders, policymakers, and other stakeholders can use to assess the quality of psychedelic science. Addressing today's problems is necessary to find out whether the optimism regarding the therapeutic potential of psychedelics has been warranted and to avoid history repeating itself.

Keywords: open science; psychedelics; psychotherapy; questionable research practices; validity.

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Conflict of interest statement

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. This project was supported by a VIDI grant from the Netherlands Organization for Scientific Research (NWO; grant id# VI.Vidi.191.107).

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References

    1. Carhart-Harris R, Giribaldi B, Watts R, et al.. Trial of psilocybin versus escitalopram for depression. N Engl J Med 2021; 384: 1402–1411. - PubMed
    1. Griffiths RR, Johnson MW, Carducci MA, et al.. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double-blind trial. J Psychopharmacol 2016; 30: 1181–1197. - PMC - PubMed
    1. Bogenschutz MP, Ross S, Bhatt S, et al.. Percentage of heavy drinking days following psilocybin-assisted psychotherapy vs placebo in the treatment of adult patients with alcohol use disorder: a randomized clinical trial. JAMA Psychiatry 2022; 79: 953–962. - PMC - PubMed
    1. Mitchell JM, Bogenschutz M, Lilienstein A, et al.. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 2021; 27: 1025–1033. - PMC - PubMed
    1. Canuso CM, Singh JB, Fedgchin M, et al.. Efficacy and safety of intranasal esketamine for the rapid reduction of symptoms of depression and suicidality in patients at imminent risk for suicide: results of a double-blind, randomized, placebo-controlled study. Focus 2019; 17: 55–65. - PMC - PubMed

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