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

NCT06796361 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-05-28

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Ketanserin 40mg plus Psilocybin 40mg

40mg Ketanserin oral will be administered followed by 40mg Psilocybin.

DRUG

40mg Psilocybin

Placebo oral followed by 40mg Psilocybin one hour later.

DRUG

20mg Psilocybin

Placebo oral followed by 20mg Psilocybin one hour later.

DRUG

10mg Psilocybin

Placebo oral followed by 10mg Psilocybin oral one hour later.

DRUG

5mg Psilocybin

Placebo oral followed by 5mg Psilocybin one hour later

OTHER

Placebo

Oral Placebo followed by oral Placebo one hour later

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-21
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06796361 on ClinicalTrials.gov