Magic mushroom compound studied in healthy volunteers for brain and body effects
NCT ID NCT07433452
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study gives 50 healthy adults a one-time dose of psilocybin (the active ingredient in magic mushrooms) or a placebo to measure changes in brain waves, blood chemicals, and empathy. Participants must have never used psychedelics before. The goal is to understand the biological and psychological effects of psilocybin, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or Female adults ages 21-65 at the time of screening. * Females of childbearing potential must have a negative pregnancy test at all designated visits. * Have a self-reported interest in psychedelic drugs and altered states of consciousness. * Never have used a classic, serotonergic psychedelic (such as psilocybin, psilocybin, LSD, or ayahuasca) or a dissociative anesthetic such as ketamine or PCP), or maximum one experience 5 years before the study starting without untoward effects. * Participants must be free of current or past substance use dependence or disorders, as determined by a semi-structured clinical interview for DSM-5 diagnoses (SCID-DSM-5). * Have a Body Max Index (BMI) 18-34 kg/m2 and an abdomen circumference ≤ 90 for women and 97 for men. * In the investigator's opinion, participants are reliable and willing and able to comply with the protocol requirements and procedures. * In addition to meeting the inclusion criteria outlined, it is important to develop a positive rapport between all individuals both participating in and coordinating the study. Exclusion Criteria: * Any psychiatric, cardiovascular, neurological, or other disorders that may be aggravated by participation in the study, or complicate interpretation of the study's results. * Any substance use disorder. * For women, a positive pregnancy test, or not using a reliable method of birth control. * Personal or family history of severe psychiatric disorders (schizophrenia, bipolar disorder, addiction, ASD) and/or psychosis in the first and second degree. * During the interview family history is asked in detail. Example: Did your parents or grandparents received a diagnosis of schizophrenia, bipolar disorder, depression.... Did somebody die by suicide? ...Did somebody was hospitalized in a psychiatric hospital? Did somebody in the family was judged "strange"? Different? Even if 40 years ago the diagnosis of depression or bipolar disorder was less precise, do you have the impression that somebody was sick? * A resting blood pressure \> 140 systolic and 90 diastolic (mmHg). * Cardiovascular diseases including valvulopathy. * Current tricyclic antidepressant, lithium, SSRIs, first- and second-generation ketamine antipsychotics, or MAOI prescription regimen. * Current dietary supplementation of 5-hydroxytryptophan and St. John's Wort. * Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. CLRC \< 30 ml/min etc.). * History of serious suicide attempts requiring hospitalization. * Significant history of mania (determined by study psychiatrist and medical records). * Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder. * Blood or needle phobia. * Participants who do not agree to use an acceptable contraceptive method throughout their participation in study. * Use of contraindicated medication.
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As listed by the trial registrant
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How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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