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Psychedelics and Entactogens:Challenges Associated With Schedule I Therapeutic Development

Consult the DEA documents: The Controlled Substances Act and Drug Scheduling

These substances exhibit potential neuroplastic and immunomodulatory effects, and are being investigated for potential uses in various psychiatric and neurological disorders that have high unmet needs, such as depression, anxiety, post-traumatic stress disorder, substance use disorder, cluster headache, and migraine. Based on current research on botanically derived and synthetic substances, limited, acute administration with varying dose ranges (low/micro to high) seems to provide benefit. The psychoactive effects and abuse potential are an important consideration, and must be balanced when designing therapeutic applications for the real world.

The abuse potential of these psychoactive substances contributed to their Schedule I classification by the FDA. The CSA outlines the reasons and factors that determine whether a product needs to be controlled.

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Psychedelics and Entactogens

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