Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05252598 |
| Other study ID # |
REB21-1797 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
January 2023 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Optimi Health Corporation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Psilocybin is a natural psychoactive alkaloid component of more than 200 species of naturally
growing mushrooms that can be found throughout the world. Psilocybin use as a ceremonious
ritual has been well documented in ancient Aztec and Mesoamerican history. Psilocybin was
chemically isolated and synthesized in the 1950s by American scientists, who found that
mushroom varieties offered varying ranges of natural psilocybin (from 0.2-1% of dry weight).
The psychological benefits of psilocybin are well-documented, as are the safety profile, low
toxicity, and significant lack of abuse or overdose potential in comparison to other
scheduled and non-scheduled drug, including alcohol. Many clinical studies demonstrate the
benefit of psilocybin on feelings of depression, mood, and overall feelings of well-being,
particularly at higher doses greater than 25mg. At these doses, hallucinations and
psychedelic effects also occur. A growing body of evidence suggests that extremely low doses,
or microdoses, may offer similar psychological benefits to individuals without any
hallucinogenic effect that may impair daily function. The purpose of this study is to examine
an optimal small/microdose of psilocybin, taken orally, that may provide such benefits.
Optimi,is committed to providing MELOCIN, an oral, pharmaceutical grade, but naturally
derived, mushroom powder (Psilocybe cubensis), containing a specific dose of psilocybin and a
controlled range of other natural compounds and excipients within the formulation. Clinical
studies will inform the desired low to very low psilocybin dosing range for specific
indications which do not elicit any psychedelic effects but are correlated to specific mood
and cognition-related enhancements or improvements in otherwise healthy individuals.
Primary objective: To assess the safety and tolerability of varying low doses and microdoses
of Optimi psilocybin-containing mushroom powder in healthy humans.
Secondary objective: To assess the magnitude of effects of varying low doses and microdoses
of Optimi psilocybin-containing mushroom powder on general mood, physiological responses,
cognitive performance, focus, and feelings of anxiety.
Methodology: Double-blind, randomized, placebo-controlled trial examining effects of six oral
doses of MELOCIN, a psilocybin-containing Psilocybe cubensis mushroom powder, with 0
(placebo), 1, 2, 5, 8 and 10mg of psilocybin, administered on six separate test days in a
randomized fashion. Participants will be randomized to the order that doses are administered.
Study days will be scheduled 6-9 days apart to avoid any carry-over effects of a previous
dose. Each study day will require ingestion of 10 capsules, which will be a combination of
placebo and Psilocybe cubensis powder containing the prescribed daily dose. On the placebo
study day, participants will digest 9 placebo capsules and one Chaga mushroom (non-active,
non-hallucinogenic) capsule such that the mushroom after-taste commonly present with
hallucinogenic magic mushrooms is mimicked and still present to preserve the blinding of the
study dosing regimen.
Participants will be scheduled for 7 total weekly visits (6 dosing days, 1 follow up/close
out visit) at the study clinic, each estimated to be 8-9 hours in duration. At each weekly
study visit, participants will be continuously monitored and asked to complete cognitive,
mood, and other psychological questionnaires and provide minimal blood work at 80-105 mins,
2.5 hrs, 5 hrs, and 7.5hrs post-drug administration in order to monitor the physiological and
psychological effects of the dose provided that day. At the follow-up visit, final
questionnaires will be completed and qualitative feedback on the experience will be collected
