drugset / Trial / NCT06796361

Role of the Serotonin 2A Receptor in Psilocybin-induced Altered States of Consciousness

NCT06796361

Phase 1 Recruiting 16 enrolled University Hospital, Basel, Switzerland
RandomizedCrossoverTriple-blindBasic science

Summary

Psilocybin (active compound of "magic mushrooms") is a prototypical psychedelic substance that acts via agonism on serotonin (5-HT) 2A receptors. Psilocybin is rapidly metabolized into its active metabolite psilocin. Psilocybin is currently under investigation as potential treatment for various neuropsychiatric disorders. Psilocybin is also widely used for recreational purposes and as research tool in neuroscience. Besides its current clinical development, a clear characterization of the dose-response relationship of psilocybin is lacking. With the present study the investigators aim to close this knowledge gap by administering low (5mg) to high (40mg) single doses of psilocybin to healthy participants. Besides its agonism on 5-HT2A receptors, psilocin also binds to other receptors and inhibits serotonin transporters (SERT). To this data only few studies have investigated these effects and never at a high dose.

Timeline

Start
2025-04-21
Primary completion
2026-08
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketanserin Small molecule 40 mg Oral
Subject Psilocybin Other / unclassified 5 mg Oral
Subject Psilocybin Other / unclassified 10 mg Oral
Subject Psilocybin Other / unclassified 20 mg Oral
Subject Psilocybin Other / unclassified 40 mg Oral

Indications

No indication recorded.