Investigating the effects of psilocybin on consciousness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the dose-response relationship of psilocybin, a psychedelic compound, by administering varying doses (5mg to 40mg) to healthy participants. The research will utilize modern psychometric instruments to assess the subjective effects of psilocybin and examine the role of the serotonin 2A receptor in these altered states of consciousness. Participants will receive both psilocybin and placebo treatments in a randomized order, with a focus on understanding the pharmacological effects of psilocybin and its metabolite psilocin. The study seeks to fill a knowledge gap regarding the physiological and psychological impacts of psilocybin at different dosages.

Why it matters

Who can join: the full rules

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 it's running

• Clinical Trial Unit
  Basel, Canton of Basel-City, Switzerland Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.