NCT05305105

Effects of Psilocybin in Post-Treatment Lyme Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Treatment Lyme Disease
• Chronic Lyme Disease
• Lyme Disease, Chronic

Interventions

Type	Name	Description
DRUG	Psilocybin	Dosing at the first session will be 15mg. For the second session participants will either remain at the initial dose, or increase to 25mg.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-10-26
• Completion: 2025-04-07
• First posted: 2022-03-31
• Last updated: 2025-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study