Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06001749
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-08-14
Brief Title:
Psilocybin in Cancer Pain Study
Sponsor:
Yvan Beaussant MD MSci
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients with Advanced Cancer
Status:
RECRUITING
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:
None
Brief Summary:
The overall objective of this study is to assess the feasibility safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer
The name of the study intervention used in this research study is
Psilocybin a tryptamine derivative
The name of the study intervention used in this research study is
Psilocybin a tryptamine derivative
Detailed Description:
This study is a phase 2 open label single center concurrent mixed-methods trial to assess the feasibility of a novel palliative-care informed psilocybin-assisted psychotherapy regimen to alleviate opioid-refractory pain in patients with advanced-cancer Psilocybin works on the serotonin system in the brain which is linked to the regulation of mood motivation and impulse control
Psilocybin is an Investigational drug meaning that the study drug has not been approved by the US Food and Drug Administration FDA as a treatment for any disease However investigators have permission from the FDA to use this drug in this research study
The research study procedures include screening for eligibility an electrocardiogram blood tests and the study intervention includes preparation evaluations one psilocybin session and follow up visits
Participants will be followed for up to 12 weeks approximately 3 months after receiving the study treatment
It is expected that about 15 people will take part in this research study
Filament Health is supporting this research study by providing the study investigational medication psilocybin
Cy Biopharma and Pancreatic Cancer North America are supporting this research study by providing funding
Psilocybin is an Investigational drug meaning that the study drug has not been approved by the US Food and Drug Administration FDA as a treatment for any disease However investigators have permission from the FDA to use this drug in this research study
The research study procedures include screening for eligibility an electrocardiogram blood tests and the study intervention includes preparation evaluations one psilocybin session and follow up visits
Participants will be followed for up to 12 weeks approximately 3 months after receiving the study treatment
It is expected that about 15 people will take part in this research study
Filament Health is supporting this research study by providing the study investigational medication psilocybin
Cy Biopharma and Pancreatic Cancer North America are supporting this research study by providing funding
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