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

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of psilocybin, a substance found in "magic mushrooms," on the brain and how it alters our state of consciousness. Researchers want to better understand how different doses of psilocybin (ranging from low to high) affect healthy adults. By doing this, they aim to gather important information that could help in developing new treatments for mental health conditions.

To participate, you should be between 25 and 75 years old, speak German well enough to understand the study, and be willing to follow the study guidelines, including not using certain drugs. Participants will need to refrain from driving or operating machinery for 48 hours after taking the substance. It's also important to note that individuals with certain medical or psychiatric conditions, those who smoke or drink heavily, and pregnant or nursing women cannot take part in this trial. If you join, you can expect to take a single dose of psilocybin and help researchers learn more about its effects.

Gender

ALL

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.