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CompletedEarly Phase 1

Precision Functional Brain Mapping in Psilocybin

NCT04501653 · Psilocybin PFM · Washington University School of Medicine

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
11
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This project will employ functional brain imaging to study the mechanism and immediate and long-term effects of psilocybin, a serotonin receptor 2A agonist, on cortical and cortico-subcortical brain networks in healthy adults.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Functional Connectivity

    Measured over 1 week

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 40 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: 1. men and woman between 18 and 40 years of age; 2. Have used a psychedelic substance within the previous 5 years but not within the last 6 months 3. No active psychiatric conditions requiring treatment with psychotropic medications (may be included if psychiatric condition is stable and participant is willing to discontinue medication for 1 month prior to participation with permission from their treating provider); 4. Able to provide informed consent. Exclusion Criteria: 1. Presence of medical conditions that may confound results of imaging study or that are contraindications to psilocybin exposure (e.g. neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy); 2. No prior exposure to classic psychedelics (psilocybin, LSD, ayahuasca, mescaline); 3. Presence of psychiatric conditions that may confound interpretation of results or that are contraindications to psilocybin exposure (e.g. major mood disorder, current substance use disorder, personal or immediate family history (parents, siblings) of any schizophrenia spectrum disorders); 4. Use of psychotropic medication during the study; 5. Presence of contraindications to MRI scanning (implantable devices, bone hardware, IUD). 6. Prior adverse reactions to psychedelics, based on the Challenging Experiences Questionnaire administered during initial screening

Where

1 study site

FacilityCityRegionCountry
Washington UniversitySt LouisMissouriUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04501653 on ClinicalTrials.gov →

Last updated in the registry 2025-10-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits