24 Participants NeededMy employer runs this trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how psilocybin, a compound in certain mushrooms, affects thinking and learning in healthy adults. Participants will receive either psilocybin or a placebo and complete computer tasks to measure cognitive changes. The study also examines how personal experiences during the trial relate to these changes. Ideal participants have previously used psychedelics without negative effects and maintain stable mental and physical health. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

Past studies have generally found psilocybin safe for humans. Research shows that while it can temporarily affect some thinking abilities, most people tolerate it well. One review found that only a few trials reported serious side effects. Another study showed that psilocybin did not significantly alter attention, mood, or thinking skills in controlled environments. Although the long-term safety of psilocybin remains unclear, current evidence suggests it is safe for short-term use.12345

Why do researchers think this study treatment might be promising?

Most treatments for cognitive impairment involve medications like cholinesterase inhibitors or memantine, which adjust neurotransmitter levels to improve memory and thinking. But psilocybin works differently, targeting serotonin receptors in the brain. This novel approach could potentially create new neural connections, enhancing cognitive functions in a unique way. Researchers are excited about psilocybin because it may offer faster and more enduring improvements in cognition compared to current treatments, which often take longer to show effects and may not work for everyone.

What evidence suggests that psilocybin might be an effective treatment for cognitive effects?

Research has shown that psilocybin, which participants in this trial may receive, can enhance emotional empathy, aiding in better understanding of others' feelings. However, it does not significantly alter thinking skills or social interactions. One study found that psilocybin increased mental flexibility and self-understanding, suggesting it may help people think differently and gain personal insights. Despite this, evidence on whether psilocybin improves overall thinking or emotional abilities remains mixed, with some studies not supporting these claims.12367

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have cancer or other major health issues. Participants should not be taking medications that could interact with psilocybin and must meet basic safety requirements set by the study team.

Inclusion Criteria

Agree to use highly effective birth control for at least one month prior to enrollment and for the duration of study enrollment, with acceptable methods including IUD, implanted or injected hormonal method, documented permanent sterilization, documented inability to become pregnant, or oral/intravaginal/transdermal hormones plus barrier contraception; two forms of contraception required with barrier or hormonal methods; abstinence alone not acceptable
Agree to inform investigators within 48 hours of any new medical conditions, treatments, or procedures
Agree to store phone and car keys in locked storage during dosing session and stay on site for at least 6 hours after drug administration until cleared by physician
See 11 more

Exclusion Criteria

Unwilling or unable to stop cannabis use at least one week prior to enrollment and refrain during study, verified by urine drug screens
Currently pregnant, nursing, intending pregnancy or fatherhood within 3 months, intending to donate sperm or eggs within 3 months, or not practicing highly effective birth control as per inclusion criteria
Positive urine drug screen or alcohol breathalyzer on any study visit or unwillingness to provide tests
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dosing

Participants receive a single dose of either psilocybin or inert placebo and complete several computer-based behavioral tasks

1 day
1 visit (in-person)

Follow-up

Participants complete measures of subjective experience and expectancy, as well as semi-structured interviews to assess whether experience correlates with behavior

1 week
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin

Trial Overview

The study tests a single dose of psilocybin versus an inactive placebo to see how it affects thinking, learning, and belief changes in healthy adults. Participants are randomly assigned to one group and complete computer tasks and interviews.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PsilocybinExperimental Treatment1 Intervention
Group II: Inert PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials
480
Recruited
724,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39354706/

Impact of psilocybin on cognitive function: A systematic ...

Psilocybin was observed to enhance emotional empathy without significantly altering cognitive empathy and social cognition. Cognitive ...

Impact of psilocybin on cognitive function: A systematic review

Psilocybin was observed to enhance emotional empathy without significantly altering cognitive empathy and social cognition.

Impact of psilocybin on cognitive function: A systematic ...

Psilocybin was observed to enhance emotional empathy without significantly altering cognitive empathy and social cognition. Cognitive ...

Psychedelics Research and Psilocybin Therapy

Previous studies by Johns Hopkins Medicine researchers showed that psychedelic treatment with psilocybin relieved major depressive disorder symptoms in adults ...

Cognitive and subjective effects of psilocybin microdosing

In conclusion, our findings do not support the idea that microdosing psilocybin reliably enhances cognitive or emotional functioning beyond ...

How Psychedelics Affect the Brain

Based on a recent study, a controlled dose of psilocybin may have therapeutic effects for relieving mental health conditions like depression, ...

Psilocybin's effects on cognition and creativity: A scoping ...

Of the few studies that explicitly reported safety outcomes (26%), only one reported serious adverse reactions.