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Safety of Microdose Psilocybin for Home Use

This study is looking into the safety of giving small doses of psilocybin trihydrate (a psychedelic compound) at home to healthy people. We want to find out which microdoses are safe for home use in future studies. You would receive different small doses of psilocybin trihydrate (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg) and a placebo (an inactive substance that looks like the real drug) on separate days. Researchers will check your blood pressure, heart rate, and perform field sobriety tests to see how your body reacts. To join, you need to be a healthy adult between 21 and 60 years old, have a high school education, and be fluent in English. This study plans to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with 20 healthy participants. You will receive different doses of psilocybin trihydrate and a placebo in a double-blind way, meaning neither you nor the researchers will know which dose you are receiving at the time.
What's involved
You will have an initial screening appointment (about 4 hours) and then 5 separate dosing sessions in the laboratory. During these sessions, you will receive the study drugs and undergo safety assessments.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure and heart rate will be measured up to 4 hours after each dose, and field sobriety testing will be done up to 90 minutes after each dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06450210

Safety for Home Administration of Microdose Psilocybin Use

Completed
PHASE1Ages 21–60Interventional
Johns Hopkins University
~17 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:psilocybin trihydratePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Systolic and Diastolic Blood pressure (mmHg)
Measured over Baseline, 1-4 hours post dose
+3 more outcomes measured

Conditions

Psychedelic Experiences

Explore related trials

Healthy Volunteers

NCT06450210

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • 5510 Nathan Shock Drive

    Baltimore, Marylandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sandeep M. Nayak, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Systolic and Diastolic Blood pressure (mmHg)Baseline, 1-4 hours post dose

    Blood pressure will be measured at 60, 120, 180, and 240 minutes. A dose will be deemed safe for home dosing if participants do not have elevations in blood pressure beyond threshold values; systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 90mmHg) at any timepoint.

  • Heart rate in beats per minute (bpm)Baseline; 1-4 hours post dose

    Heart rate will be measured at 60, 120, 180, and 240 minutes. A dose will be deemed safe for home dosing if participants do not have elevations in heart rate beyond threshold value of \> 110 bpm

  • Field sobriety testingBaseline; 90 minutes post dose

    The standardized battery of field sobriety tests includes: The Walk-and-Turn (W\&T), One-Leg Stand (OLS), Horizontal Gaze Nystagmus (HGN). A dose will be deemed safe for home dosing if participants pass field sobriety testing at time of expected peak psilocybin effects. The cumulative amount of clues observed across these tasks (out of a possible 22 clues) will be reported.

  • Number of participants with normal or abnormal psychological status as assessed by a psychiatric mental status exam120 minutes post dose

    The Psychiatric Mental Status Exam will be a clinical interview identical to that performed by psychiatrists in daily clinical practice and will assess and document the participant's mood, affect, thought process (including the presence of formal thought disorder), paranoia, delusions, hallucinations, other perceptual alterations, speech (including rate, volume, prosody, whether or not speech is pressured), suicidal thoughts, and orientation to person, place and time. A dose will be deemed safe for home dosing if there is no evidence of abnormal psychological status on a psychiatric mental status exam performed by a blinded study psychiatrist. There is no formal scoring rubric for this outcome. A psychiatrist will use their clinical judgment to evaluate whether a participant has normal or abnormal psychological status based on a clinical interview.