Practical considerations in the establishment of psychedelic research programs.

Establishing psychedelic research programs at academic medical centers in the United States faces unique obstacles because psychedelics are intensely psychoactive, carry sociopolitical baggage, and most are Schedule I drugs. This article reviews academic literature and draws on the authors' experiences with regulatory agencies and conducting basic science, investigator-initiated, and industry-sponsored psychedelic trials. It recommends that investigators cultivate broad institutional support early and anticipate challenges in securing funding, obtaining FDA Investigational New Drug approval, sourcing clinical-grade drug, getting DEA Schedule I researcher registration and any required state license, preparing treatment and storage spaces, managing controlled substance inventory, and engaging the local community. With planning, persistence, and expert assistance, these hurdles are likely surmountable.

Study at a glance

Abstract

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. 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. 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. 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. 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.