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RecruitingPhase 1

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

NCT06796361 · PDR · University Hospital, Basel, Switzerland

Recruiting
Status
Accepting participants
Phase 1
Phase
16
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • 5 dimensions of altered state of consciousness (5D-ASC) total OAV score

    Measured over 10 hours after substance administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 75 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: 1. Age between 25 and 75 years. 2. Sufficient understanding of the German language. 3. Understanding the procedures and the risks that are associated with the study. 4. Participants must be willing to adhere to the protocol and sign the consent form. 5. Participants must be willing to refrain from taking illicit psychoactive substances during the study (not including cannabis). 6. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration. 7. Women of childbearing potential must be willing to use effective birth-control throughout study participation Exclusion Criteria: 1. Chronic or acute medical condition, including a history of seizures. 2. Body mass index 18-29.9 kg/m2 3. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders). 4. Psychotic or bipolar disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g., brain injury, dementia, or lesions of the brain. 5. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg) 6. Psychedelic substance use (with the exception of cannabis) more than 20 times or any time within the previous two months 7. Pregnant or nursing women. 8. Participation in another clinical trial (currently or within the last 30 days). 9. Use of medications that may interfere with the effects of the study medications (any psychiatric medications and any medication with known to interact with the study substances). 10. Tobacco smoking (\>10 cigarettes/day). 11. Consumption of alcoholic drinks (\>15 drinks / week). 12. Body weight \< 45 kg.

Where

1 study site

FacilityCityRegionCountry
Clinical Trial UnitBaselCanton of Basel-CitySwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06796361 on ClinicalTrials.gov →

Last updated in the registry 2025-05-28. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits