Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847686
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-04-26
Brief Title:
Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase 12 Study of a Group Model of Psilocybin-Assisted Therapy for Cancer-Related Anxiety in Patients With Metastatic Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 III trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety andor depression Psilocybin is a substance being studied in conjunction with therapy for the treatment of anxiety and depression in patients with cancer In this study the psilocybin being used is derived from the mushroom psilocybe cubensis using a patented process that results in a pharmaceutical grade version of psilocybin Psilocybin acts by activating serotonin receptors on brain cells which can change perceptions and patterns of thinking in ways that may decrease anxiety
Detailed Description:
OUTLINE
Patients receive psilocybin orally PO and participate in group and individual therapy sessions on trial
Patients receive psilocybin orally PO and participate in group and individual therapy sessions on trial
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 |
|---|---|---|---|
| FHIRB0020001 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |
| NCI-2023-02948 | REGISTRY | None | None |