Psychedelic ExperiencesPhase 1NCT06450210
Safety for Home Administration of Microdose Psilocybin Use
A Phase 1 study testing psilocybin trihydrate in people with Psychedelic Experiences, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychedelic Experiences
- What is being tested?
- psilocybin trihydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study aims to enroll 20 healthy participants who will complete all study procedures. Participants will undergo a standard screening procedure. Baseline measures will be completed before the first dose. Participants will then be given ascending doses of psilocybin trihydrate (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg) and a single, interspersed, randomized placebo on separate days in double-blind fashion at the research site. A 1 mg dose of psilocybin anhydrate is equivalent to a 1.19 mg dose of psilocybin trihydrate (used in this study). For each session, participants will be assessed with criteria for the safety of home dosing. If any dose meets criteria for at-home dosing, and a lower dose did not fail these criteria, that dose will be identified as the safe dose for the given participant. After administration of all doses of psilocybin to all participants, if a safe at-home dose was identified for all participants, that will be considered the highest safe dose for at-home administration to be used for future studies.
Visit summary:
Initial screening: Medical and psychological screening (Approx. 4 hours though portions of this may be completed remotely).
Dosing sessions: There will be 5 double-blind laboratory dosing sessions involving administration of ascending doses of psilocybin and a single, interspersed, randomized placebo dose. Baseline questionnaires will be completed on the day of the first dosing visit, and safety assessments will be administered during and at the end of each session.
- Conditions
- Psychedelic Experiences
- Being tested
- psilocybin trihydrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psilocybin trihydrateDrug
Microdoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).
PlaceboDrug
Participants will receive a capsule identical in appearance to the active drug that contains an inactive substance.
| Study group | Role | What they receive |
|---|---|---|
| 1.2 mg psilocybin trihydrate microdose | Experimental | Participants will receive a single microdose of 1.2 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion. Receives: Drug: psilocybin trihydrate |
| 2.0 mg psilocybin trihydrate microdose | Experimental | Participants will receive a single microdose of 2.0 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion. Receives: Drug: psilocybin trihydrate |
| 3.0 mg psilocybin trihydrate microdose | Experimental | Participants will receive a single microdose of 3.0 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion. Receives: Drug: psilocybin trihydrate |
| 4.2 mg psilocybin trihydrate microdose | Experimental | Participants will receive a single microdose of 4.2 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion. Receives: Drug: psilocybin trihydrate |
| Placebo | Placebo comparator | Participants will receive a single placebo oral capsule in the laboratory in double-blind fashion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic Blood pressure (mmHg)
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.
Measured: Baseline, 1-4 hours post dose
Heart rate in beats per minute (bpm)
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
Measured: Baseline; 1-4 hours post dose
Field sobriety testing
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.
Measured: Baseline; 90 minutes post dose
Number of participants with normal or abnormal psychological status as assessed by a psychiatric mental status exam
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.
Measured: 120 minutes post dose
Secondary outcomes (1)
Driving Performance as assessed by The Systems Technology, Inc. Simulation (STISIM) Drive® M4000-R Console
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Specific driving outcomes include: lateral control (i.e., SDLP), longitudinal control (i.e., standard deviation of speed (SDSP), mean speed, number of speed exceedances), total accidents (sum of number of collisions, pedestrians hit, etc.), total rule violations (sum of number of missed stop signs, illegal turns, etc.), and distance to lead vehicles.
Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Measured: Baseline; 60 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start6 Dec 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychedelic ExperiencesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Private Philanthropic Funds
- Responsible party
- Sponsor
- Investigators
- Sandeep M. Nayak, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450210
- Sponsor's protocol ID
- IRB00422973
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety for Home Administration of Microdose Psilocybin Use
- ClinicalTrials.gov ID
- NCT06450210
- Acronym / sponsor ID
- IRB00422973
- Conditions
- Psychedelic Experiences
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Private Philanthropic Funds
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to enroll 20 healthy participants who will complete all study procedures. Participants will undergo a standard screening procedure. Baseline measures will be completed before the first dose. Participants will then be given ascending doses of psilocybin trihydrate (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg) and a single, interspersed, randomized placebo on separate days in double-blind fashion at the research site. A 1 mg dose of psilocybin anhydrate is equivalent to a 1.19 mg dose of psilocybin trihydrate (used in this study). For each session, participants will be assessed with criteria for the safety of home dosing. If any dose meets criteria for at-home dosing, and a lower dose did not fail these criteria, that dose will be identified as the safe dose for the given participant. After administration of all doses of psilocybin to all participants, if a safe at-home dose was identified for all participants, that will be considered the highest safe dose for at-home administration to be used for future studies.
Visit summary:
Initial screening: Medical and psychological screening (Approx. 4 hours though portions of this may be completed remotely).
Dosing sessions: There will be 5 double-blind laboratory dosing sessions involving administration of ascending doses of psilocybin and a single, interspersed, randomized placebo dose. Baseline questionnaires will be completed on the day of the first dosing visit, and safety assessments will be administered during and at the end of each session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1.2 mg psilocybin trihydrate microdose | Experimental | Drug: psilocybin trihydrateParticipants will receive a single microdose of 1.2 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion. |
| 2.0 mg psilocybin trihydrate microdose | Experimental | Drug: psilocybin trihydrateParticipants will receive a single microdose of 2.0 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion. |
| 3.0 mg psilocybin trihydrate microdose | Experimental | Drug: psilocybin trihydrateParticipants will receive a single microdose of 3.0 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion. |
| 4.2 mg psilocybin trihydrate microdose | Experimental | Drug: psilocybin trihydrateParticipants will receive a single microdose of 4.2 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single placebo oral capsule in the laboratory in double-blind fashion. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psilocybin trihydrateMicrodoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg). | Drug | 1.2 mg psilocybin trihydrate microdose, 2.0 mg psilocybin trihydrate microdose, 3.0 mg psilocybin trihydrate microdose, 4.2 mg psilocybin trihydrate microdose |
| PlaceboParticipants will receive a capsule identical in appearance to the active drug that contains an inactive substance. | Drug | Placebo |
Primary outcome
Systolic and Diastolic Blood pressure (mmHg)
Time frame: 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)
Time frame: 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 testing
Time frame: Baseline; 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 exam
Time frame: 120 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.
1 secondary outcome
Driving Performance as assessed by The Systems Technology, Inc. Simulation (STISIM) Drive® M4000-R Console
Time frame: Baseline; 60 minutes post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep M. Nayak, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing psilocybin trihydrate in people with Psychedelic Experiences, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and Diastolic Blood pressure (mmHg) (time frame: Baseline, 1-4 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.