Control Conditions in Randomized Trials of Psychedelics: An ACTTION Systematic Review.

Autor:	Nayak SM; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.; Corresponding author: Sandeep M. Nayak, MD, Behavioral Pharmacology Research Unit, Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224 (smn@jhmi.edu)., Bradley MK; Department of Health Behavior, University of Alabama at Birmingham, Birmingham, Alabama., Kleykamp BA; BAK and Associates, LLC, Baltimore, Maryland., Strain EC; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland., Dworkin RH; Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York., Johnson MW; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Jazyk:	angličtina
Zdroj:	The Journal of clinical psychiatry [J Clin Psychiatry] 2023 May 10; Vol. 84 (3). Date of Electronic Publication: 2023 May 10.
DOI:	10.4088/JCP.22r14518
Abstrakt:	Objective: To systematically review control conditions of all available randomized psychedelic trials. Data Sources: We searched PubMed, PsycINFO, and EMBASE for randomized trials of psychedelics in humans from 1940 through May 2020 with no language restrictions. PRISMA guidelines were followed. (PROSPERO registration number: PROSPERO-CRD42020205341.). Study Selection: All randomized trials of psychedelics in humans from 1940 through May 2020 were included. Data Extraction: Two independent reviewers performed extraction. Extracted data included study design, demographics, blinding type, whether and how blind integrity was assessed, psychedelic used and dose, drug control condition and dose, type of non-drug control condition, number of dosing sessions, and recruitment source. Outcome data were not collected. Results: In total, 126 articles were included, encompassing 86 unique studies. Of studies with a drug control condition (80), 49 (61.2%) used an inert placebo control, 16 (20.0%) used active comparators, 12 (15.0%) used both, and 3 (3.8%) used only different active psychedelic doses as a control. Only 3 of 21 therapeutic trials compared the use of psychological support to a minimally supportive condition. The majority (81/86; 94%) of studies were blinded, though only 14 (17.3%) included blind assessment; only 8 of these 14 studies assessed participants' blinding. Blinding success, assessed in highly varied ways, was generally poor. Conclusions: Randomized psychedelic trials underutilize elements that would improve quality or provide important information: blind assessment, active drug controls, and testing psychological support against minimal-support conditions. Several queried categories, including blind integrity assessment and details of non-drug control conditions, were insufficiently reported by many reviewed studies. Recommendations are provided to improve trial methods. (© Copyright 2023 Physicians Postgraduate Press, Inc.)
Databáze:	MEDLINE
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