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
52 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
Researchers are evaluating the safety of administering microdoses of psilocybin trihydrate at home to healthy adults aged 21 to 60 years. The study aims to identify which doses can be safely taken outside a clinical setting by using ascending doses and a randomized placebo in a controlled laboratory environment. This Phase 1 study involves 20 participants and is sponsored by Johns Hopkins University. Participants will receive single oral microdoses of psilocybin trihydrate at 1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg, as well as a placebo, across five double-blind dosing sessions at the research site. The doses are given in ascending order on separate days. Baseline questionnaires and safety assessments will be completed before and during each dosing session. The study will determine the highest dose that meets safety criteria for at-home use for each participant. Participants will undergo an initial medical and psychological screening lasting about 4 hours, which may be partly remote. During each dosing visit, safety checks including blood pressure, heart rate, field sobriety tests, and psychological status exams will be conducted at specific intervals post-dose. Driving performance will be assessed at baseline and after dosing using a simulation. The total participation includes screening and five dosing sessions with monitoring to evaluate safety outcomes related to vital signs, sobriety, psychology, and driving ability.
CONDITIONS
Brief Title
Safety for Home Administration of Microdose Psilocybin Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 60 years
- Provided written informed consent
- At least a high-school level education or equivalent and fluent in English
- Healthy and psychologically stable as confirmed by medical and psychiatric screening
- Agree to avoid any psychoactive drugs, alcohol, and nicotine within 24 hours before dosing sessions except caffeine
- Agree not to take as needed medications on dosing mornings
- Agree to avoid sildenafil, tadalafil, or similar medications within 72 hours before dosing
- Agree to refrain from nonprescription, nutritional, or herbal supplements for one week before dosing except approved exceptions
- Licensed driver (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 such as 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 medications with centrally-acting serotonergic effects including MAOIs
- 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
- First-degree relative with bipolar I disorder or schizophrenia spectrum disorder
- Blood pressure at screening above 130/80 mmHg or heart rate outside 40-90 bpm range while at rest and seated or supine for at least 5 minutes
- Clinically significant ECG abnormalities as defined in exclusion criteria (e.g., QTc > 450 msec)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (approximately 4 hours, portions may be completed remotely)
Duration - 5 dosing sessions on separate days
Participants receive ascending microdoses of psilocybin trihydrate and a placebo in a double-blind fashion at the research site. Safety assessments and baseline questionnaires are completed during the dosing sessions.
5 in-person visits for dosing and safety assessments
Trial Site Locations
Total: 1 location
1
5510 Nathan Shock Drive
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
M
Matthew Nielsen Dick
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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