Mood and Cognitive Effects of Psilocybin in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Optimi Health Corporation
• Collaborator: University of Calgary
• Treatments: Psilocybin

Criteria

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