@article{e729abf05cd5482cb878fd2ceff81146,
title = "On blinding and suicide risk in a recent trial of psilocybin-assisted therapy for treatment-resistant depression",
abstract = "Results from a recent Phase II trial of psilocybin-assisted therapy for treatment-resistant depression1 suggest modest efficacy but raise concerns about potential for serious adverse effects. The study highlights the need for rigorous assessment of blinding integrity, expectancy, and further study of factors that may contribute to risk in vulnerable populations.",
author = "Natalie Gukasyan",
note = "Funding Information: Support for the author was provided by Tim Ferriss, Matt Mullenweg, Craig Nerenberg, Blake Mycoskie, and the Steven and Alexandra Cohen Foundation . The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Funding Information: Perhaps the most glaring criticism of this work is on the issue of blinding. As is widely acknowledged, the subjective effects of classic psychedelics are usually obvious enough to allow both participants and study staff to correctly guess treatment allocation in placebo-controlled trials.6 This was reconfirmed in a recent trial comparing psilocybin with diphenhydramine in patients with alcohol use disorder, in which 94% and 92% of participants and staff respectively correctly identified their treatment condition after the first dose.7 The medium dose (10 mg) condition in Goodwin et al.1 could have provided novel insights on the role of expectancy if it was determined to be a convincing comparison condition with the high dose. Unfortunately, the authors failed to collect any data on blinding integrity. Given the ubiquitous concern about this issue and the ease with which this data could have been collected, its omission seems remarkable and highlights the need for more publicly funded clinical trials. Of note, less than two weeks after these results were published, National Institute of Mental Health (NIMH) released a Notice of Information indicating that clinical trials using psychedelics without rigorous assessment of blinding integrity would be considered of low funding priority.8Support for the author was provided by Tim Ferriss, Matt Mullenweg, Craig Nerenberg, Blake Mycoskie, and the Steven and Alexandra Cohen Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The author is a co-investigator on a study of psilocybin for major depressive disorder funded by Usona Institute. Publisher Copyright: {\textcopyright} 2022 Elsevier Inc.",
year = "2023",
month = jan,
day = "13",
doi = "10.1016/j.medj.2022.12.003",
language = "English (US)",
volume = "4",
pages = "8--9",
journal = "Med",
issn = "2666-6359",
publisher = "Cell Press",
number = "1",
}