Considerations in assessing the abuse potential of psychedelics during drug development
Neuropharmacology November 28, 2022 Steven Galati, Dominic Chiapperino, Silvia N. Calderon et al. 14 citations
The abuse potential of classic psychedelics—serotonergic 5-HT2A agonists such as psilocybin—has not been systematically assessed using modern methods since they were placed in Schedule I of the Controlled Substances Act in 1970. This paper reviews the scientific evaluation of their abuse potential and outlines the data required to support a rescheduling recommendation if a classic psychedelic drug product receives FDA approval. The authors argue that renewed clinical research necessitates revisiting these drugs' regulatory classification, given that Schedule I status assumes high abuse potential and no accepted medical use, a designation that may no longer align with current evidence.