This perspective article (2024) for investigators at academic medical centres in the United States provides recommendations for establishing psychedelic research programs. It highlights challenges including funding, regulatory approvals, sourcing controlled substances, preparing study spaces, managing controlled substances, and engaging the local community, and offers strategies to anticipate and surmount these obstacles.
Abstract of Practical considerations in the establishment of psychedelic research programs
“Rationale There is increasing interest in establishing psychedelic research programs at academic medical centers. 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.
Objectives 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.
Methods 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.
Results 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.
Conclusions 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.”
Authors: Brian S. Barnett, M. Frances Vest, Marcus S. Delatte, Franklin King IV, Erin E. Mauney, Anthony J. Coulson, Sandeep M. Nayak, Peter S. Hendricks, George R. Greer & Kevin S. Murnane
Summary of Practical considerations in the establishment of psychedelic research programs
The therapeutic potential of psychedelics has garnered increasing attention in recent years, spurred by financial support from federal, state, and private entities. Many academic medical centres in the United States have begun conducting or planning psychedelic studies. However, these compounds, classified as Schedule I drugs, pose unique challenges due to their psychoactive nature, regulatory restrictions, and historical stigma.
While the FDA has issued guidance on trial design and personnel qualifications, researchers have little formal instruction on navigating practical hurdles. This paper aims to distil the authors’ extensive experience into actionable recommendations for establishing psychedelic research programmes, particularly at academic institutions.
Cultivating Institutional Support
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Practical considerations in the establishment of psychedelic research programs
https://doi.org/10.1007/s00213-024-06722-6
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Cite this paper (APA)
Barnett, B. S., Vest, M. F., Delatte, M. S., King IV, F., Mauney, E. E., Coulson, A. J., ... & Murnane, K. S. (2024). Practical considerations in the establishment of psychedelic research programs. Psychopharmacology, 1-17.