Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05592379
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-11
First Post:
2022-10-19
Brief Title:
Consciousness Psilocybin and Well-Being
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Consciousness and Psilocybin Effects on Well-Being The CoPE Study Pilot Phase
Status:
ENROLLING_BY_INVITATION
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:
CoPE Pilot
Brief Summary:
This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them
Detailed Description:
The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes Subsequently the pre-treatment of 02 mg of clonidine was added
This design involves testing up to two psilocybinclonidine administration protocols in asleep and awake subjects and one of two IV psilocybin only administration protocols in awake subjects
The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 02 mg oral clonidine in sleeping subjects If either the 2-minute or 10-minute psilocybin infusion plus oral clonidine protocols allow sleep maintenance up to 5 subjects will while awake receive the same psilocybin infusion protocol administered to sleeping subjects including clonidine Subsequently this same infusion protocol may be administered without clonidine to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects Group 1C for 2-minute psilocybin infusion Group 2C for 10-minute psilocybin infusion should a significant effect of clonidine on the awake psychedelic experience be suspected For individual subjects that are dosed first while asleep and then up to twice while awake each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit
Adaptive Study Design Change per Protocol Amendment Approved 52124
This design involves testing up to two psilocybinclonidine administration protocols in asleep and awake subjects and one of two IV psilocybin only administration protocols in awake subjects
The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 02 mg oral clonidine in sleeping subjects If either the 2-minute or 10-minute psilocybin infusion plus oral clonidine protocols allow sleep maintenance up to 5 subjects will while awake receive the same psilocybin infusion protocol administered to sleeping subjects including clonidine Subsequently this same infusion protocol may be administered without clonidine to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects Group 1C for 2-minute psilocybin infusion Group 2C for 10-minute psilocybin infusion should a significant effect of clonidine on the awake psychedelic experience be suspected For individual subjects that are dosed first while asleep and then up to twice while awake each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit
Adaptive Study Design Change per Protocol Amendment Approved 52124
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 |
|---|---|---|---|
| A532017 | OTHER | None | None |
| Protocol Version 642024 | OTHER | None | None |
| 233897 | OTHER | OnCore ID | None |