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However, psychedelics are intensely psychoactive, carry considerable sociopolitical baggage, and most are Schedule I drugs, creating significant potential impediments to implementation. There is little formal guidance for investigators on navigating the complex on-the-ground obstacles associated with establishing psychedelic research programs.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Objectives<\/jats:title>\n            <jats:p>This article provides recommendations that may be helpful to investigators seeking to work with psychedelics, with a focus on academic medical centers in the United States.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>The academic literature on relevant matters is reviewed, and the authors provide observations from their experiences either working for relevant regulatory agencies or conducting basic science studies, investigator-initiated trials, or industry sponsored trials with psychedelics.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Investigators planning to conduct psychedelic research should cultivate broad institutional support early. Challenges related to securing funding, obtaining approval for an Investigational New Drug application from the Food and Drug Administration, clinical grade drug sourcing, obtaining a Schedule I researcher registration from the Drug Enforcement Administration and an equivalent state license (if required), preparing spaces for treatment and study drug storage, managing controlled substance inventory, engaging the local community, and other issues should be anticipated.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Investigators should anticipate several implementation challenges when planning to work with psychedelics. However, these are likely surmountable with planning, persistence, and assistance from colleagues and other experts.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00213-024-06722-6","type":"journal-article","created":{"date-parts":[[2024,12,4]],"date-time":"2024-12-04T03:58:15Z","timestamp":1733284695000},"page":"27-43","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Practical considerations in the establishment of psychedelic research programs"],"prefix":"10.1007","volume":"242","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8963-5701","authenticated-orcid":false,"given":"Brian S.","family":"Barnett","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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He has also served on advisory boards for CB Therapeutics, Compass Pathways, Janssen Pharmaceuticals, and Livanova. He receives monetary compensation for editorial work for DynaMed Plus (EBSCO Industries, Inc). He has received research funding from Compass Pathways, MindMed, and Reunion Neuroscience. Within the last two years he has consulted for Cerebral. MSD is an employee of Allucent. FK holds stock in Compass Pathways and Cybin. He also serves on the scientific advisory board for Apex Labs. He has consulted for Cybin in the last two years and has received monetary compensation from Vital for teaching. He has received research support from Tryp Therapeutics. EEM has received research support from Tryp Therapeutics. AC is a retired Assistant Special Agent in Charge of the Drug Enforcement Administration who, as an element of that position, had supervisory oversight of the local DEA Diversion Control Program which has Federal regulatory responsibility over Schedule I researchers. AC is a paid regulatory consultant for Mind Medicine, Inc, Multidisciplinary Association of Psychedelic Studies, and the Arizona Criminal Justice Commission. AC has also performed paid regulatory consultancies for Usona Institute, Pacific Neurological Institute Foundation, Fungi Perfecti, Freedom Biosciences, Journey Clinical, and a paid Subject Matter Expert for the US Health and Human Services, Substance Abuse and Mental Health Services Administration. Support for SMN through the Johns Hopkins Center for Psychedelic and Consciousness Research was provided by Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven and Alexandra Cohen Foundation. SMN was also co-investigator on a psilocybin clinical trial funded by Usona Institute. PSH is on the scientific advisory board of Bright Minds Biosciences Ltd., Eleusis Benefit Corporation, Journey Colab Corporation, and Reset Pharmaceuticals Inc. GRG is the President of the Heffter Research Institute. The other authors declare no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}