NCT06796361 Role of the Serotonin 2A Receptor in Psilocybin-induced Altered States of Consciousness
| NCT ID | NCT06796361 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2025-04-21 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06796361 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 75 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06796361 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06796361 currently recruiting?
Yes, NCT06796361 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Basel, Switzerland to inquire about joining.
Where is the NCT06796361 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06796361 clinical trial?
NCT06796361 is sponsored by University Hospital, Basel, Switzerland. The trial plans to enroll 16 participants.