Mood and Cognitive Effects of Psilocybin in Healthy Participants

NCT05252598 | Withdrawn Early Phase 1

• 1 other identifier: REB21-1797
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mood Disturbance; Mood Change; Sleep Disturbance; Drug Effect; Psychedelic Experiences; Health, Subjective; Psilocin Toxicity; Psilocybin Toxicity; Psilocybin Causing Adverse Effects in Therapeutic Use; Anxiety

Keywords

Psilocybin; Magic Mushrooms; Microdose; Mood; Sleep; Cognition

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  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)

  Assessment of hallucinogenic effects or unpleasant side effects assessed using the validated 5D-ASC questionnaire

  Up to 96 hours post-drug administration

Secondary Outcomes (1)

• Assessments of physiological effects of psilocybin capsules

  Up to 96 hours post-drug administration

Study Arms (6)

Placebo Arm

PLACEBO COMPARATOR

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 Psilocybin Arm

EXPERIMENTAL

9 placebo pills and 1 capsule containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 1mg of psilocybin

Drug: Psilocybin

2mg Psilocybin Arm

EXPERIMENTAL

8 placebo pills and 2 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 2mg of psilocybin

Drug: Psilocybin

5mg Psilocybin Arm

EXPERIMENTAL

5 placebo pills and 5 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 5mg of psilocybin

Drug: Psilocybin

8mg Psilocybin Arm

EXPERIMENTAL

2 placebo pills and 8 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 8mg of psilocybin

Drug: Psilocybin

10mg Psilocybin Arm

EXPERIMENTAL

0 placebo pills and 10 capsules containing encapsulated mushroom powder formulation (derived from Psilocybe cubensis strain) for 10mg of psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

1mg encapsulated psilocybin

Also known as: Melocin

10mg Psilocybin Arm; 1mg Psilocybin Arm; 2mg Psilocybin Arm; 5mg Psilocybin Arm; 8mg Psilocybin Arm

Inonotus Obliquus Whole Extract DRUG

1mg encapsulated chaga mushroom

Also known as: Chaga

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pacemaker or implanted cardiac defibrillator
• Previous head trauma or concussion history

Sponsors & Collaborators

• Optimi Health Corporation: lead
• University of Calgary: collaborator

MeSH Terms

Conditions

Parasomnias; Anxiety Disorders

Interventions

Psilocybin; Mezlocillin

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds

Study Officials

• Valerie Taylor, MD/PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 23, 2022
• Study Start: January 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share