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

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ClinicalTrials.gov Identifier: NCT05252598
Recruitment Status : Not yet recruiting
First Posted : February 23, 2022
Last Update Posted : February 23, 2022
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Optimi Health Corporation

Tracking Information
First Submitted Date  ICMJE January 27, 2022
First Posted Date  ICMJE February 23, 2022
Last Update Posted Date February 23, 2022
Estimated Study Start Date  ICMJE April 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2022)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2022)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mood and Cognitive Effects of Psilocybin in Healthy Participants
Official Title  ICMJE Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects ("MELO"): A Blinded, Placebo-Controlled, Dose-Finding Study
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Participants will be assigned a blister pack containing all the pills for the duration of the study. Each participant will consume 10 capsules each day of the study. The investigational agent will be an encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) containing varying amounts of psilocybin. The formulation will be altered to ensure each day contains the proposed amount of psilocybin (1, 2, 5, 8, 10mg) or placebo to be tested. Participants and researchers will be blinded to the dose which was consumed on each day of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mood Disturbance
  • Mood Change
  • Sleep Disturbance
  • Drug Effect
  • Psychedelic Experiences
  • Health, Subjective
  • Psilocin Toxicity
  • Psilocybin Toxicity
  • Psilocybin Causing Adverse Effects in Therapeutic Use
  • Anxiety
Intervention  ICMJE
  • Drug: Psilocybin
    1mg encapsulated psilocybin
    Other Name: Melocin
  • Drug: Inonotus Obliquus Whole Extract
    1mg encapsulated chaga mushroom
    Other Name: Chaga
Study Arms  ICMJE
  • 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)
    Intervention: Drug: Inonotus Obliquus Whole Extract
  • Experimental: 1mg Psilocybin Arm
    9 placebo pills and 1 capsule containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 1mg of psilocybin
    Intervention: Drug: Psilocybin
  • Experimental: 2mg Psilocybin Arm
    8 placebo pills and 2 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 2mg of psilocybin
    Intervention: Drug: Psilocybin
  • Experimental: 5mg Psilocybin Arm
    5 placebo pills and 5 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 5mg of psilocybin
    Intervention: Drug: Psilocybin
  • Experimental: 8mg Psilocybin Arm
    2 placebo pills and 8 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 8mg of psilocybin
    Intervention: Drug: Psilocybin
  • Experimental: 10mg Psilocybin Arm
    0 placebo pills and 10 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 10mg of psilocybin
    Intervention: Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2022)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Simone Withecomb, BHsC 403-210-8334 impact@ucalgary.ca
Contact: Pamela Ovadje, PhD 403-210-8436 impact@ucalgary.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05252598
Other Study ID Numbers  ICMJE REB21-1797
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share data at this time.
Current Responsible Party Optimi Health Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Optimi Health Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Calgary
Investigators  ICMJE
Principal Investigator: Valerie Taylor, MD/PhD University of Calgary
PRS Account Optimi Health Corporation
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP