Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450210
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-04
Brief Title:
Safety for Home Administration of Microdose Psilocybin Use
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Safety for Home Administration of Microdose Psilocybin Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 single-blind fashion The participants will be asked to complete questionnaires and undergo safety assessments
Eligible participants will be given ascending doses of psilocybin trihydrate and a single interspersed randomized placebo on separate days in single-blind fashion The participants will be asked to complete questionnaires and undergo safety assessments
Detailed Description:
This study aims to enroll 20 healthy participants who will complete all study procedures Participants will undergo a standard screening procedure Baseline measures will be completed before the first dose Participants will then be given ascending doses of psilocybin trihydrate 12 mg 20 mg 30 mg and 42 mg and a single interspersed randomized placebo on separate days in single-blind fashion at the research site A 1 mg dose of psilocybin anhydrate is equivalent to a 119 mg dose of psilocybin trihydrate used in this study For each session participants will be assessed with criteria for the safety of home dosing If any dose meets criteria for at-home dosing and a lower dose did not fail these criteria that dose will be identified as the safe dose for the given participant After administration of all doses of psilocybin to all participants if a safe at-home dose was identified for all participants that will be considered the highest safe dose for at-home administration to be used for future studies
Visit summary
Initial screening Medical and psychological screening Approx 4 hours though portions of this may be completed remotely
Dosing sessions There will be 5 single-blind laboratory dosing sessions involving administration of ascending doses of psilocybin and a single interspersed randomized placebo dose Baseline questionnaires will be completed on the day of the first dosing visit and safety assessments will be administered during and at the end of each session
Visit summary
Initial screening Medical and psychological screening Approx 4 hours though portions of this may be completed remotely
Dosing sessions There will be 5 single-blind laboratory dosing sessions involving administration of ascending doses of psilocybin and a single interspersed randomized placebo dose Baseline questionnaires will be completed on the day of the first dosing visit and safety assessments will be administered during and at the end of each session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None