Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416085
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-01-14
Brief Title:
Psilocybin-assisted Existential Attachment and RelationaL PEARL Therapy for Patients With Advanced Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Psilocybin-assisted Existential Attachment and RelationaL PEARL Therapy for Patients With Advanced Cancer A Phase II Open-Label Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The PEARL Pilot is a phase II open-label trial Participants will receive a single high-dose 25 mg of psilocybin in the context of Psilocybin-assisted Existential Attachment and RelationaL PEARL therapy
Detailed Description:
Individuals with advanced cancer often experience high levels of distress due to physical suffering difficult treatment decisions social isolation and fear of death While there are many treatment options for the management of physical symptoms associated with cancer there are relatively few standard treatment approaches to help patients deal with psychological and existential suffering Over the past decade research has shown that psychotherapies incorporating existential attachment and relational approaches can address the specific needs and challenges of the advanced cancer population and thus help to reduce distress Simultaneously recent research has shown that psilocybin-assisted psychotherapy in which an individual ingests the psychoactive drug within the carefully monitored therapeutic setting can reduce end-of-life distress and greatly benefit those with advanced disease The multidisciplinary team has combined these two evidence-based approaches into what the team calls Psilocybin-assisted Existential Attachment and RelationaL PEARL therapy PEARL therapy combines elements from psilocybin-assisted psychotherapy including preparatory therapy sessions a high-dose drug session and integration sessions with important elements from manualized individual psychotherapies designed for patients with advanced cancer This study will assess the feasibility acceptability and safety of PEARL therapy among patients with advanced cancer This study will yield important information about the feasibility of this type of therapy and contribute to the growing research around the efficacy of psychedelic-assisted therapies This type of therapy has the potential to improve quality of life among those with advanced disease and careful research is needed to build upon previous findings to outline the necessary components of therapy and guide public policy legislation and clinical guidelines
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 |
|---|---|---|---|
| 21-5781 | OTHER | University Health Network | None |