Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05351541
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2022-04-22
Brief Title:
Psilocybin Therapy for Chronic Low Back Pain
Sponsor:
Joshua Woolley MDPhD
Organization:
University of California San Francisco
Study Overview
Official Title:
A Double-blind Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
Status:
RECRUITING
Status Verified Date:
2024-01
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:
POP
Brief Summary:
This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively Patients may be recruited at Stanford and University of California San Francisco UCSF study procedures will occur at UCSF Each participant will receive a dose of psilocybin with possibly one or more other drugs Participants will undergo two preparation sessions a dosing session three integration sessions to discuss their psilocybin experience and several follow up sessions
Detailed Description:
Chronic pain is associated with higher levels of pain-related distress depression emotional dysfunction helplessness hopelessness and suicidality Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively The investigators will determine whether psilocybin therapy improves patients ability to cope with chronic low back pain If psilocybin therapy is an effective treatment in this population its use could be incorporated into interventions for chronic low back pain and other psychological conditions
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