Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05506982
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-08-06
Brief Title:
Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
The Safety Feasibility and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain P-PC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain Cancer patients often experience demoralization which is characterized by feelings of hopelessness loss of meaning and existential distress Psilocybin psychotherapy together with multidisciplinary palliative and supportive care may help treat the anxiety depression and chronic pain felt by cancer survivors - defined here as cancer patients from time of diagnosis through the end-of-life
Detailed Description:
PRIMARY OBJECTIVE
I To determine the safety feasibility and acceptability of a single administration of 25 mg psilocybin psilocybin provided under supportive conditions with multidisciplinary palliative care support P-PC in adult cancer survivors living with concurrent demoralization and chronic pain
EXPLORATORY OBJECTIVE
I To evaluate for changes in demoralization anxiety depression quality of life pain other symptoms mysticism awe post-traumatic growth social isolation and psychosocial functioning from baseline to end-of-treatment to 35-month follow up
OUTLINE
Patients receive psilocybin orally PO and undergo observation for up to 8 hours on day 14
After completion of study intervention patients are followed up on days 15 21 42 56 and 98
I To determine the safety feasibility and acceptability of a single administration of 25 mg psilocybin psilocybin provided under supportive conditions with multidisciplinary palliative care support P-PC in adult cancer survivors living with concurrent demoralization and chronic pain
EXPLORATORY OBJECTIVE
I To evaluate for changes in demoralization anxiety depression quality of life pain other symptoms mysticism awe post-traumatic growth social isolation and psychosocial functioning from baseline to end-of-treatment to 35-month follow up
OUTLINE
Patients receive psilocybin orally PO and undergo observation for up to 8 hours on day 14
After completion of study intervention patients are followed up on days 15 21 42 56 and 98
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 |
|---|---|---|---|
| NCI-2020-13913 | REGISTRY | None | None |
| STUDY00001905 | OTHER | None | None |
| EU5206-20 | OTHER | None | None |
| P30CA138292 | NIH | Emory University HospitalWinship Cancer Institute | httpsreporternihgovquickSearchP30CA138292 |