Actively Recruiting

Phase 1
Age: 25Years - 75Years
All Genders
Healthy Volunteers
NCT06796361

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

Led by University Hospital, Basel, Switzerland · Updated on 2025-05-28

16

Participants Needed

1

Research Sites

66 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 25Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 25 and 75 years
  • Sufficient understanding of the German language
  • Understanding the procedures and risks associated with the study
  • Willingness to follow the study protocol and sign the consent form
  • Willingness to refrain from taking illicit psychoactive substances during the study, except cannabis
  • Willingness not to drive or operate machinery within 48 hours after substance administration
  • Women of childbearing potential must agree to use effective birth control throughout the study
Not Eligible

You will not qualify if you...

  • Chronic or acute medical conditions, including a history of seizures
  • Body mass index outside 18-29.9 kg/m2
  • Current or past major psychiatric disorders such as psychotic disorders, mania, hypomania, or anxiety disorders
  • Psychotic or bipolar disorder in first-degree relatives, excluding secondary causes like brain injury or dementia
  • High blood pressure (above 140/90 mmHg) or low blood pressure (below 85 mmHg)
  • More than 20 uses of psychedelic substances (except cannabis) or use within the last two months
  • Pregnancy or breastfeeding
  • Participation in another clinical trial currently or within the last 30 days
  • Use of medications that might interfere with study drugs, including psychiatric medications
  • Smoking more than 10 cigarettes per day
  • Drinking more than 15 alcoholic drinks per week
  • Body weight below 45 kg

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinical Trial Unit

Basel, Canton of Basel-City, Switzerland, 4056

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

6

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