WithdrawnEarly Phase 1

Mood and Cognitive Effects of Psilocybin in Healthy Participants

NCT05252598 · MELO · Optimi Health Corporation

Closed to entry

Status

Not accepting participants

Early Phase 1

Phase

—

Target enrolment

—

Study sites

What it is testing

Summary

This study is seeking to find the optimal microdose or low dose of psilocybin (magic mushrooms) that provides general enhancements to mood, memory, sleep, and other measures of general well-being without any hallucinogenic effects.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Incidence of Adverse Events
Measured over Up to 96 hours post-drug administration
Tolerability of doses with regard to reported hallucinogenic or unpleasant effects (Altered States of Consciousness Scale (5D-ASC), self-reported experience)
Measured over Up to 96 hours post-drug administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 50 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: 1. Healthy volunteers 2. Between the age of 18 and 50 years of age 3. Good physical health as determined by medical history, medication history, blood and urinalysis work up 4. Willing to provide informed written consent 5. Able to complete self-assessment questionnaires provided in English 6. Agree to refrain from using any psychoactive drugs, including alcohol, marijuana, or nicotine, at least 24 hours prior to each study visit 7. Agree to refrain from using any non-prescription medication at least 24 hours prior to each study visit Exclusion Criteria: 1. Unable to complete self-assessment questionnaires in English 2. Reported history of drug abuse or addiction 3. History of any neurological, cardiovascular, or psychiatric disorders or conditions. 4. History, family history in first degree (blood) relatives, or current screening symptoms (as determined by positive mini-international neuropsychiatric interview (MINI) questionnaire) of psychiatric illness (including depression, anxiety disorder, post-partum depression, bipolar disorder, schizophrenia). 5. History of insulin-dependent diabetes mellitus 6. Epilepsy with history of seizures 7. Female participants who are pregnant or nursing 8. Prescribed medications with centrally-active serotonergic or gamma-aminobutyric acid (GABA)-receptor interactions, such as monoamine oxidase inhibitors (MAOI) antidepressants, serotonin-inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), or neurosteroids 9. Pacemaker or implanted cardiac defibrillator 10. Previous head trauma or concussion history

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05252598 on ClinicalTrials.gov →

Last updated in the registry 2023-03-20. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Indication