Mood and Cognitive Effects of Psilocybin in Healthy Participants (MELO)

March 16, 2023 updated by: Optimi Health Corporation

Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects ("MELO"): A Blinded, Placebo-Controlled, Dose-Finding Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Arm
9 placebo pills and 1 non-hallucinogenic Chaga (Inonotus obliquus) mushroom powder capsule to mimic the after-taste of active Psilocybin pills (Psilocybe cubensis)
Drug: Inonotus Obliquus Whole Extract
1mg encapsulated chaga mushroom
Other Names:
  • Chaga
Experimental: 1mg Psilocybin Arm
9 placebo pills and 1 capsule containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 1mg of psilocybin
Drug: Psilocybin
1mg encapsulated psilocybin
Other Names:
  • Melocin
Experimental: 2mg Psilocybin Arm
8 placebo pills and 2 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 2mg of psilocybin
Drug: Psilocybin
1mg encapsulated psilocybin
Other Names:
  • Melocin
Experimental: 5mg Psilocybin Arm
5 placebo pills and 5 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 5mg of psilocybin
Drug: Psilocybin
1mg encapsulated psilocybin
Other Names:
  • Melocin
Experimental: 8mg Psilocybin Arm
2 placebo pills and 8 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 8mg of psilocybin
Drug: Psilocybin
1mg encapsulated psilocybin
Other Names:
  • Melocin
Experimental: 10mg Psilocybin Arm
0 placebo pills and 10 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 10mg of psilocybin
Drug: Psilocybin
1mg encapsulated psilocybin
Other Names:
  • Melocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Up to 96 hours post-drug administration
Collection of data from participants regarding adverse events experience during or after administration of the study drug.
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)
Time Frame: Up to 96 hours post-drug administration
Assessment of hallucinogenic effects or unpleasant side effects assessed using the validated 5D-ASC questionnaire
Up to 96 hours post-drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessments of physiological effects of psilocybin capsules
Time Frame: Up to 96 hours post-drug administration
Use of validated questionnaires to assess drug-effects on mood, sleep, memory, cognition, anxiety and depression
Up to 96 hours post-drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optimi Health Corporation

Collaborators

University of Calgary

Investigators

  • Principal Investigator: Valerie Taylor, MD/PhD, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB21-1797

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share data at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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