CompletedPhase 1

Psilocybin Brain Stimulation and Imaging Pilot Study

United States10 participantsStarted 2025-04-18

Plain-language summary

This open-label pilot psilocybin administration study investigates the influence of psilocybin on brain function and cognitive control functions in clinically and psychiatrically healthy volunteers. Participants will undergo experimental drug administration sessions after careful screening and preparation. Participants will also have brain activity measured using electroencephalogram (EEG) also during non-invasive brain stimulation using Transcranial Magnetic Stimulation (TMS).

Who can participate

Age range

22 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have given written informed consent * Right handed * Between the ages of 22 and 55 years old * Have a high school level of education * Be medically healthy and psychologically stable as determined by screening for medical problems via a personal interview, medical history and physical examination, psychiatric interview, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests * Fluent in English and capable of providing informed consent * Willing to remove any jewelry, hair clips, bobby pins, or any other potentially conducting or magnetic objects worn on or near the head * Have a minimum of 2 lifetime uses of a hallucinogen (e.g., Lysergic acid diethylamide (LSD), psilocybin mushrooms, N,N-dimethyltryptamine (DMT), ayahuasca, mescaline, Salvia divinorum, ketamine, dextromethorphan (DXM) , and phencyclidine (PCP). Only psychoactive and recreational use of the hallucinogenic drugs, including dextromethorphan and ketamine, will be factored into the calculation of lifetime use. * Cigarette smokers must agree to abstain from smoking on session days from 1 hour before drug administration * Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. Exceptions include daily use of caffeine and nicotine. * Agree that for one week before each session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute Change in Inhibitory EEG Component Amplitudes (N45, N100) from Baseline

Timeframe: Baseline up to approximately 1.5 hours post psilocybin adminstration

Change in Mystical Experience Questionnaire (MEQ30)

Timeframe: Baseline up to to approximately 1.5 hours post psilocybin administration

Trial details

NCT IDNCT06835699

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-21

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