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Safety for Home Administration of Microdose Psilocybin Use

NCT06450210 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

  • Psychedelic Experiences

Interventions

DRUG

psilocybin trihydrate

Microdoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).

DRUG

Placebo

Participants will receive a capsule identical in appearance to the active drug that contains an inactive substance.

Sponsors & Collaborators

Principal Investigators

  • Sandeep M. Nayak, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-06
Primary Completion
2026-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06450210 on ClinicalTrials.gov