WithdrawnEarly Phase 1psilocybin

Mood and Cognitive Effects of Psilocybin in Healthy Participants

Sponsored by Optimi Health Corporation

NCT ID
NCT05252598
0
Start Date
2023-01
Est. Completion
2023-12

About This 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.

Conditions Studied

Mood DisturbanceMood ChangeSleep DisturbanceDrug EffectPsychedelic ExperiencesHealth, SubjectivePsilocin ToxicityPsilocybin ToxicityPsilocybin Causing Adverse Effects in Therapeutic UseAnxiety

Interventions

  • Psilocybin
  • Inonotus Obliquus Whole Extract

Eligibility

Age:18 Years - 50 Years
Healthy Volunteers:Yes
View full eligibility 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

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

Mood and Cognitive Effects of Psilocybin in Healthy Participants | Huxley