Status:
WITHDRAWN
Mood and Cognitive Effects of Psilocybin in Healthy Participants
Lead Sponsor:
Optimi Health Corporation
Collaborating Sponsors:
University of Calgary
Conditions:
Mood Disturbance
Mood Change
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
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 with...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05252598
Start Date
January 1 2023
End Date
December 1 2023
Last Update
March 20 2023
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