Actively Recruiting
Safety for Home Administration of Microdose Psilocybin Use
Led by Johns Hopkins University · Updated on 2026-02-23
20
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
P
Private Philanthropic Funds
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety for Home Administration of Microdose Psilocybin Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 60 years
- Written informed consent provided
- At least a high school education or equivalent and fluent in English
- Healthy and psychologically stable as determined by medical and psychiatric screening including interview, physical exam, ECG, and lab tests
- Agree to avoid all psychoactive drugs including alcohol and nicotine within 24 hours before dosing except caffeine
- Agree not to take as needed medications on dosing mornings
- Agree not to take sildenafil, tadalafil, or similar medications within 72 hours before dosing
- Agree to avoid nonprescription, nutritional, or herbal supplements for one week before dosing unless approved by investigators
- Licensed to drive (for driving simulator test)
You will not qualify if you...
- Women who are pregnant, nursing, or of child-bearing potential not using effective birth control
- Cardiovascular conditions including coronary artery disease, stroke, angina, uncontrolled hypertension, significant ECG abnormalities, artificial heart valve, or recent transient ischemic attack
- Epilepsy
- Insulin-dependent diabetes or history of hypoglycemia if taking oral hypoglycemics
- Daily use of psychoactive drugs including nicotine (except caffeine)
- Regular use of centrally-acting serotonergic medications including MAOIs unless discontinued for sufficient time
- Body weight more than 20% above or below ideal range
- History of schizophrenia spectrum disorder, bipolar I disorder, or substance-induced psychotic disorder
- Current moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)
- First degree relative with bipolar I disorder or schizophrenia spectrum disorder
- Blood pressure at screening above 130/80 mmHg or heart rate outside 40 to 90 beats per minute range at rest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
5510 Nathan Shock Drive
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
M
Matthew Nielsen Dick
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
5
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