Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644170
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of a Second Psilocybin Group Retreat for Partial Responders With Anxiety Associated With Metastatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started primary site to other places in the body metastatic and had a partial response to their first retreat Up to 50 of patients with metastatic cancer have clinically significant anxiety and unaddressed anxiety and distress may add to the suffering caused by cancer itself Psilocybin a psychedelic drug is made using an extract from the psilocybe mushroom also known as magic mushrooms Psilocybin binds to serotonin receptors natural body chemicals that control moods on brain cells producing intense changes in mood including anxiety This may change perceptions and patterns of thinking in ways that may decrease anxiety Group therapy may reduce stress and improve the well-being and quality of life of patients with metastatic cancer A second episode of psilocybin-assisted group therapy may be safe tolerable and or effective in treating anxiety and distress in partial responders with metastatic cancer
Detailed Description:
OUTLINE
Patients receive psilocybin orally PO with optional booster dose on day 0 Patients attend an individual prep visit on day -1 and an individual integration visit on day 1 Patients also attend group preparation visits on days -14 -7 and -1 and group integration visits on days 1 8 22 and 36
After completion of study treatment patients are followed up at 2 3 and 6 months
Patients receive psilocybin orally PO with optional booster dose on day 0 Patients attend an individual prep visit on day -1 and an individual integration visit on day 1 Patients also attend group preparation visits on days -14 -7 and -1 and group integration visits on days 1 8 22 and 36
After completion of study treatment patients are followed up at 2 3 and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None