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CompletedPhase 1

Safety for Home Administration of Microdose Psilocybin Use

NCT06450210 · Johns Hopkins University

Closed to entry
Status
Not accepting participants
Phase 1
Phase
17
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The goal of this laboratory study is to establish whether and which microdoses of psilocybin are safe to administer at home to healthy participants. Eligible participants will be given ascending doses of psilocybin trihydrate and a single, interspersed, randomized placebo on separate days in double-blind fashion. The participants will be asked to complete questionnaires and undergo safety assessments.

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

  • Systolic and Diastolic Blood pressure (mmHg)

    Measured over Baseline, 1-4 hours post dose

  • Heart rate in beats per minute (bpm)

    Measured over Baseline; 1-4 hours post dose

  • Field sobriety testing

    Measured over Baseline; 90 minutes post dose

  • Number of participants with normal or abnormal psychological status as assessed by a psychiatric mental status exam

    Measured over 120 minutes post dose

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

21 Years to 60 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * 21 to 60 years old * Have given written informed consent * Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English * Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests * Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. * Agree not to take any as needed (PRN) medications on the mornings of drug sessions * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration. * Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals. * Licensed to drive (for driving simulator test). Exclusion Criteria: * Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control. * Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation, corrected QT interval (QTc) \> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year * Epilepsy * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia * Currently taking psychoactive drugs (prescribed or not) on a daily basis. This includes nicotine but excepts caffeine. * Currently taking on a regular (e.g. daily) basis any medications having a centrally-acting serotonergic effect, including monoamine oxidase inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose. * More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table * History of schizophrenia spectrum disorder * History of bipolar I disorder * History of substance induced psychotic disorder * Current history of meeting Diagnostic and Statistical Manual (DSM)-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) * Have a first degree relative with bipolar I disorder, or schizophrenia spectrum disorder. Cardiovascular screening: To qualify for the study, blood pressure at screening will be less than 130 mmHg systolic, 80 mmHg diastolic, and 90 beats per minute; mean heart rate must also be no less than 40 beats per minute. Blood pressure will be taken while subjects are at rest and have been seated or supine for at least 5 minutes.

Where

1 study site

FacilityCityRegionCountry
5510 Nathan Shock DriveBaltimoreMarylandUnited 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.

NCT06450210 on ClinicalTrials.gov →

Last updated in the registry 2026-08-14. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits