Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355414
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-26
Brief Title:
Psilocybin in Chronic Low Back Pain and Depression
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Psilocybin and Affective Function in Chronic Lower Back Pain Depression
Status:
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 study seeks to provide insight on psilocybins effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression CLBPD
Participants will receive either a single high-dose of psilocybin 25mg absolute dose or methylphenidate 40mg absolute dose Participants will be asked to complete assessments of pain depressive symptoms and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects
Participants will receive either a single high-dose of psilocybin 25mg absolute dose or methylphenidate 40mg absolute dose Participants will be asked to complete assessments of pain depressive symptoms and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects
Detailed Description:
This study will investigate the effects of a single experimental psilocybin 25 mg fixed dose administration compared to a dose of methylphenidate 40 mg fixed dose Assessments will be conducted during screening visits before and after the drug session at follow up visits up to 1-month after the drug session as well as periodically throughout study participation via a multi-time-per-day survey application Forty participants will complete all study visits including follow-up visits
Primary objectives
1 Investigate the feasibility safety and acceptability of psilocybin for CLBPD
2 Investigate the effect of psilocybin on self-report of positive affect negative affect and pain catastrophizing
3 Investigate the effect of psilocybin on a behavioral task called positive affective pain inhibition
Secondary objectives
1 Investigate the durability 1-month follow-up effects of psilocybin on self-report of positive affect negative affect and pain catastrophizing
2 Investigate the effect of psilocybin on dynamic associations between affective measures pain and function on a moment-to-moment basis
Primary objectives
1 Investigate the feasibility safety and acceptability of psilocybin for CLBPD
2 Investigate the effect of psilocybin on self-report of positive affect negative affect and pain catastrophizing
3 Investigate the effect of psilocybin on a behavioral task called positive affective pain inhibition
Secondary objectives
1 Investigate the durability 1-month follow-up effects of psilocybin on self-report of positive affect negative affect and pain catastrophizing
2 Investigate the effect of psilocybin on dynamic associations between affective measures pain and function on a moment-to-moment basis
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 |
|---|---|---|---|
| R33AT012317 | NIH | None | httpsreporternihgovquickSearchR33AT012317 |