Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT05305105
Status:
COMPLETED
Last Update Posted:
2025-08-20
First Post:
2022-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Psilocybin in Post-Treatment Lyme Disease
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Effects of Psilocybin in Post-Treatment Lyme Disease
Status:
COMPLETED
Status Verified Date:
2025-08
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 will examine the effects of psilocybin on Lyme disease symptom burden and quality of life in people with Post-Treatment Lyme Disease (PTLD).
Detailed Description:
This pilot study will evaluate the therapeutic potential of psilocybin in people with well-documented current Post-Treatment Lyme Disease (PTLD). Study measures will assess the impact of psilocybin-assisted treatment on overall symptom burden and quality of life in 20 people with PTLD. This is an open-label proof-of-concept trial in which participants will complete an 8-week course of study treatment including two psilocybin sessions (15mg in week 4 and 15 or 25mg in week 6) with psychological support, and follow-up assessments 1, 3, and 6 months after the final psilocybin session.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 132642 | OTHER | Steven & Alexandra Cohen Foundation | View |