Practical considerations in the establishment of psychedelic research programs.
Brian S. Barnett, M Frances Vest, Marcus S Delatte, Franklin King Iv, Erin Mauney, Anthony J Coulson, Sandeep M. Nayak, Peter S. Hendricks, George Greer, Kevin S. Murnane
Psychopharmacology 2025 DOI: 10.1007/s00213-024-06722-6 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | LSD Psilocybin |
| Keywords | Psychedelic research psychedelics Hallucinogens Entheogens Medical testing Drug trials Clinical research Clinical trials |
| Citations | 20 |
| Key findings | Investigators planning psychedelic research at US academic medical centers should anticipate and address challenges in funding, regulatory approvals, drug sourcing, facility preparation, and community engagement, but these obstacles are likely surmountable with planning and expert assistance. |
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.
Comparable studies
Other narrative reviews on LSD, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Study of a New Schizophrenomimetic Drug—Sernyl | 1959 | Review | |
| Classic psychedelics: An integrative review of epidemiology, therapeutics, mystical experience, and brain network function. General population | 2019 | Integrative review | |
| The Pharmacology of Lysergic Acid Diethylamide: A Review | 2008 | Review | |
| Serotonin research: contributions to understanding psychoses | 2008 | Review | |
| ADVERSE REACTIONS TO PSYCHEDELIC DRUGS. A REVIEW OF THE LITERATURE | 1984 | Review |
Citations in the library
Cited by 20
- Key competencies for psychedelic treatment in real-world mental health care settings. General Hospital Psychiatry 2025
- Funding Success of United States Federal Grant Applications Proposing to Study Therapeutic Applications of Psychedelics: A Survey Study Psychoactives February 5, 2025
- A Scoping Review of Research in Naturalistic Studies with Psychedelics. Journal of Psychoactive Drugs June 28, 2025
- The utility of 2,5-dimethoxy-4-iodoamphetamine for the study of serotonin 2A and 2C receptors. Molecular Pharmacology 2026
- Approved and Pipeline Pharmacological Interventions for Eating Disorders (2010–2025): 15 Years of Progress (or Lack Thereof) CNS Drugs November 28, 2025
and 15 more in the library
Cites 20
- Human hallucinogen research: guidelines for safety. Journal of Psychopharmacology July 1, 2008
- Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2 agonist action Neuroreport December 1, 1998
- Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder JAMA Psychiatry August 24, 2022
- Constructing drug effects: A history of set and setting Drug Science, Policy and Law 2017
- Prediction of Psilocybin Response in Healthy Volunteers PLoS One February 17, 2012
and 15 more in the library