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NCT06450210 · ClinicalTrials.gov registry record · Phase 1
Safety for Home Administration of Microdose Psilocybin Use
A Phase 1 study of Psychedelic Experiences, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06450210: Recruiting Phase 1 study of Psychedelic Experiences, sponsored by Johns Hopkins University.
NCT06450210 is a Phase 1 study of Psychedelic Experiences that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 20 participants, below the 36-participant average among 4 other Psychedelic Experiences trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06450210, a Phase 1 study of Psychedelic Experiences, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Blood pressure will be measured at 60, 120, 180, and 240 minutes. A dose will be deemed safe for home dosing if participants do not have elevations in blood pressure beyond threshold values; systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 90mmHg) at any timepoint.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG psilocybin trihydrate
Study Locations (1)
Maryland
- 5510 Nathan Shock Drive - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-12-06 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06450210 shows while recruiting
NCT06450210 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 36-participant average among 4 other Psychedelic Experiences trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Psychedelic Experiences appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06450210 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06450210 about?
NCT06450210 is a clinical study titled "Safety for Home Administration of Microdose Psilocybin Use". 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...
What is the current status of trial NCT06450210?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-12-06. Estimated completion is 2027-07.
What conditions does trial NCT06450210 study?
This clinical trial studies the following conditions: Psychedelic Experiences.
What interventions are being tested in trial NCT06450210?
The interventions under investigation include: Placebo (DRUG), psilocybin trihydrate (DRUG).
Who is sponsoring clinical trial NCT06450210?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06450210 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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