Safety of taking microdoses of psilocybin at home
Safety for Home Administration of Microdose Psilocybin Use
PHASE1 · Johns Hopkins University · NCT06450210
This study is testing if it's safe for healthy people to take small doses of psilocybin at home to help set guidelines for future use.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06450210 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the safety of administering microdoses of psilocybin trihydrate at home for healthy participants. A total of 20 participants will receive ascending doses of psilocybin and a placebo in a double-blind manner across five sessions. Participants will undergo thorough screening and safety assessments, including questionnaires and medical evaluations, to identify a safe dose for at-home use. The goal is to establish guidelines for future studies on home administration of psilocybin.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21 to 60 who are psychologically stable and can provide informed consent.
Not a fit: Patients with significant medical or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable safe home administration of psilocybin, potentially improving access to psychedelic therapies.
How similar studies have performed: While there is growing interest in the therapeutic use of psychedelics, this specific approach to home administration of microdoses is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- 5510 Nathan Shock Drive — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Sandeep M. Nayak, MD — Johns Hopkins University
- Study coordinator: Matthew Nielsen Dick
- Email: microdose@jh.edu
- Phone: 410-999-8066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psychedelic Experiences