Considerations in assessing the abuse potential of psychedelics during drug development

Summary

Psilocybin and other psychedelics, despite growing therapeutic interest in Psychiatry and Medicine, remain Schedule I drugs. This 1970 classification, based on perceived high substance abuse potential, predates modern Psychology and biochemical analysis techniques. With renewed interest in these powerful hallucinogens for mental health, their outdated scheduling demands a systematic re-evaluation of abuse potential. The absence of contemporary data from comprehensive drug studies challenges their restrictive schedule. Future assessments, utilizing advanced chemical synthesis and alkaloids analysis, will inform decisions on reclassification for psychotherapist-guided medicine.

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'.

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