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RecruitingPhase 1NCT06450210

Safety for Home Administration of Microdose Psilocybin Use

Trial Parameters

ConditionPsychedelic Experiences
SponsorJohns Hopkins University
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment20
SexALL
Min Age21 Years
Max Age60 Years
Start Date2024-12-06
Completion2026-07
Interventions
psilocybin trihydratePlacebo

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Brief Summary

The goal of this laboratory study is to establish whether and which microdoses of psilocybin are safe to administer at home to healthy participants. Eligible participants will be given ascending doses of psilocybin trihydrate and a single, interspersed, randomized placebo on separate days in double-blind fashion. The participants will be asked to complete questionnaires and undergo safety assessments.

Eligibility Criteria

Inclusion Criteria: * 21 to 60 years old * Have given written informed consent * Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English * Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests * Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. * Agree not to take any as needed (PRN) medications on the mornings of drug sessions * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration. * Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved

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