Considerations in assessing the abuse potential of psychedelics during drug development
Steven Galati, Dominic Chiapperino, Silvia N. Calderon, Katherine R. Bonson, Chad J Reissig, Joshua Lloyd
Neuropharmacology November 28, 2022 DOI: 10.1016/j.neuropharm.2022.109352 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Psilocybin |
| Keywords | Substance abuse Schedule Psychotherapist Hallucinogen |
| Citations | 14 |
| Key findings | The abuse potential of classic psychedelics has not been assessed with modern methodology since their Schedule I placement in 1970, and data needed for potential rescheduling are delineated. |
Abstract
The recent increase in clinical research on the potential therapeutic uses of classic psychedelics has prompted the need to revisit the assessment of the abuse potential of these drugs. The term "classic psychedelic" is used in this manuscript to describe serotonergic 5-HT2A agonists that alter perception, cognition, and mood (i.e., psychedelic effects) and that are currently controlled in Schedule I of the Controlled Substances Act (CSA). Schedule I drugs are subject to the most restrictive controls under the CSA, as they are considered to have a high abuse potential and no currently accepted medical use in the United States (USA). However, these classic psychedelics were placed in Schedule I at the time the CSA was enacted in 1970, and their abuse potential has not been systematically assessed using modern methodology. This paper provides an overview of scientific evaluation of the abuse potential of classic psychedelics and delineates the data that will be needed in support of a recommendation for the rescheduling, if a drug product containing a classic psychedelic gains FDA approval. This article is part of the Special Issue on 'National Institutes of Health Psilocybin Research Speaker Series'.