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. 2024 Aug;38(8):690-700.
doi: 10.1177/02698811241265756. Epub 2024 Jul 31.

A framework for assessment of adverse events occurring in psychedelic-assisted therapies

Roman Palitsky  1   2   3 , Deanna M Kaplan  1   3   4 , John Perna  2 , Zachary Bosshardt  2 , Jessica L Maples-Keller  2 , Holly F Levin-Aspenson  5 , Ali John Zarrabi  1   3   6 , Caroline Peacock  1   3   7 , Tanja Mletzko  1   2 , Barbara O Rothbaum  1   2 , Charles L Raison  1   3 , George H Grant  1   3 , Boadie W Dunlop  1   2
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Free article

A framework for assessment of adverse events occurring in psychedelic-assisted therapies

Roman Palitsky et al. J Psychopharmacol. 2024 Aug.
Free article

Abstract

Objective: Despite considerable research examining the efficacy of psychedelic-assisted therapies (PATs) for treating psychiatric disorders, assessment of adverse events (AEs) in PAT research has lagged. Current AE reporting standards in PAT trials are poorly calibrated to features of PAT that distinguish it from other treatments, leaving many potential AEs unassessed.

Methods: A multidisciplinary working group of experts involved in PAT pooled formally and informally documented AEs observed through research experience and published literature. This information was integrated with (a) current standards and practices for AE reporting in pharmacotherapy and psychotherapy trials and (b) published findings documenting post-acute dosing impacts of psychedelics on subjective states, meaning, and psychosocial health variables, to produce a set of AE constructs important to evaluate in PAT as well as recommended methods and time frames for their assessment and monitoring. Correspondence between identified potential AEs and current standards for AE assessment was examined, including the extent of coverage of identified AE constructs by 25 existing measures used in relevant research.

Results: Fifty-four potential AE terms warranting systematized assessment in PAT were identified, defined, and categorized. Existing measures demonstrated substantial gaps in their coverage of identified AE constructs. Recommendations were developed for how to assess PAT AEs (including patient, clinician, and informant reports), and when to assess over preparation, dosing session, integration, and follow-up. Application of this framework is demonstrated in a preliminary assessment protocol (available in the supplement).

Conclusions: This assessment framework addresses the need to capture post-acute dosing AEs in PAT, accounting for its pharmacotherapy and psychotherapy components, as well as documented impacts of psychedelics on worldviews and spirituality.

Keywords: Adverse events; drug/psychotherapy combination; ethics; psychedelic-assisted therapy; research design and methods.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Jessica L Maples-Keller has received research funding and consulting payments from COMPASS Pathways, and receives support from the Wounded Warrior Project (WWP), and Multidisciplinary Association of Psychedelic Studies. Barbara O Rothbaum has recently had funding from the Wounded Warrior Project, NIMH, National Science Foundation, and the Bob Woodruff Foundation. Barbara O Rothbaum receives royalties from Oxford University Press, Guilford, APPI, Psych Campus, and Emory University and received advisory board payments from Jazz Pharmaceuticals, Bioserenity, Cerebral Therapeutics, Otsuka, Psychwire, and Senseye. Barbara O Rothbaum owns equity in Virtually Better, Inc. that creates virtual environments. The terms of these arrangements have been reviewed and approved by Emory University in accordance with its conflict of interest policies. Boadie W Dunlop has received research support from Boehringer-Ingelheim, Compass Pathways, NIMH, and Usona, and has received consulting fees from Biohaven, The Department of Defense, Myriad Neuroscience, Otsuka, and Sage. Charles L Raison has received personal fees from Usona Institute and grants to Usona Institute from Dr. Bronner’s All-One, Fournier Family Foundation, Good Ventures, Steven and Alexandra Cohen Foundation, Tiny Blue Dot Foundation, Turnbull Family Foundation, William A Linton, Novartis, Sage/Biogen, Emory Healthcare, and Vail Health. Roman Palitsky, Deanna M Kaplan, John Perna, Zacchary Bosshardt, Holly F Levin-Aspenson, Ali John Zarrabi, Caroline Peacock, and George H Grant all report no disclosures. Tanja Mletzko reports no disclosures.

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