Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05317689
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-12
First Post:
2022-03-07
Brief Title:
Comparing the Effects of Psilocin and Psilocybin in Healthy Adults
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Comparison of the Effects of PEX20 oral Psilocin PEX30 sublingual Psilocin and PEX10 oral Psilocybin in Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults
Detailed Description:
The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill Twenty participants ages 25 to 50 with one previous experience with psychedelics and who meet all other inclusion and exclusion criteria at screening will be enrolled After baseline assessments participants will engage in preparatory visits with trained facilitators followed by drug administration supervised by the facilitators and a clinician who will conduct safety monitoring throughout Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience The same preparation procedures integration and supervision will be repeated up to three more times with each participant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PR202143H | OTHER | None | None |
| 156917 | OTHER | FDA | None |