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Psilocybin in Chronic Low Back Pain and Depression

Name: Psilocybin in Chronic Low Back Pain and Depression — clinical trial record (NCT06355414)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 1

SponsorJohns Hopkins University

Started2024-04-22

View on ClinicalTrials.gov ↗

This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). 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.

Amendment history 3 changes detected by DataLookout

2026-09-05

Primary completion pushed: 2026-09-30 → 2026-12-30

2026-07-25

Primary completion pushed: 2026-07-30 → 2026-09-30

2026-07-25

Completion pushed: 2026-08-30 → 2026-12-30

Trial Details

NCT Number	NCT06355414
Lead Sponsor	Johns Hopkins University Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Conditions	Chronic Low-back Pain, Depression
Enrollment	40 participants
Start Date	2024-04-22
Primary Completion	2026-12-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-09-04