WithdrawnEarly Phase 1

Mood and Cognitive Effects of Psilocybin in Healthy Participants

Stopped: The sponsor no longer wishes to pursue the methods outlined in the protocol.

0Started 2023-01

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy volunteers
✓. Between the age of 18 and 50 years of age
✓. Good physical health as determined by medical history, medication history, blood and urinalysis work up
✓. Willing to provide informed written consent
✓. Able to complete self-assessment questionnaires provided in English
✓. Agree to refrain from using any psychoactive drugs, including alcohol, marijuana, or nicotine, at least 24 hours prior to each study visit
✓. Agree to refrain from using any non-prescription medication at least 24 hours prior to each study visit

Exclusion criteria

✕. Unable to complete self-assessment questionnaires in English
✕. Reported history of drug abuse or addiction
✕. History of any neurological, cardiovascular, or psychiatric disorders or conditions.
✕. 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).
✕. History of insulin-dependent diabetes mellitus
✕. Epilepsy with history of seizures
✕. Female participants who are pregnant or nursing
✕. 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

What they're measuring

Incidence of Adverse Events

Timeframe: 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)

Timeframe: Up to 96 hours post-drug administration

Trial details

NCT IDNCT05252598

SponsorOptimi Health Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08

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