Role of the Serotonin 2A Receptor in Psilocybin-induced Altered States of Consciousness (NCT06796361) | Clinical Trial Compass
RecruitingPhase 1
Role of the Serotonin 2A Receptor in Psilocybin-induced Altered States of Consciousness
Switzerland16 participantsStarted 2025-04-21
Plain-language 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.
Who can participate
Age range25 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age between 25 and 75 years.
✓. Sufficient understanding of the German language.
✓. Understanding the procedures and the risks that are associated with the study.
✓. Participants must be willing to adhere to the protocol and sign the consent form.
✓. Participants must be willing to refrain from taking illicit psychoactive substances during the study (not including cannabis).
✓. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
✓. Women of childbearing potential must be willing to use effective birth-control throughout study participation
Exclusion criteria
✕. Chronic or acute medical condition, including a history of seizures.
✕. Body mass index 18-29.9 kg/m2
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What they're measuring
1
5 dimensions of altered state of consciousness (5D-ASC) total OAV score
Timeframe: 10 hours after substance administration
. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
✕. 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.
✕. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
✕. Psychedelic substance use (with the exception of cannabis) more than 20 times or any time within the previous two months
✕. Pregnant or nursing women.
✕. Participation in another clinical trial (currently or within the last 30 days).