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NCT06355414 · ClinicalTrials.gov registry record · Phase 1
Psilocybin in Chronic Low Back Pain and Depression
A Phase 1 study of Depression and Chronic Low Back Pain, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06355414: Recruiting Phase 1 study of Depression and Chronic Low Back Pain, sponsored by Johns Hopkins University.
NCT06355414 is a Phase 1 study of Depression and Chronic Low Back Pain that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 40 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06355414, a Phase 1 study of Depression and Chronic Low Back Pain, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Discrete positive affect items: joy, love, hope, contentment. Positive affect will be assessed by asking participants to rate the intensity of four discrete positive emotions (joy, love, hope, contentment) on a 5-point Likert scale from 1-5 ("Very slightly or not at all" to "Extremely") and averaging those discrete items. Positive Affect scores will be aggregated over 7-day EMA periods at baseline, post-session, and 1-month follow-up. Higher Positive Affect scores represent higher levels of posi
Conditions Studied
Interventions
- DRUG Psilocybin
- DRUG Methylphenidate
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-04-22 |
| Est. Completion | 2026-08-30 |
| Phase | Phase 1 |
What NCT06355414 shows while recruiting
NCT06355414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Psilocybin is the first listed.
NCT06355414 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06355414 about?
NCT06355414 is a clinical study titled "Psilocybin in Chronic Low Back Pain and Depression". 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). Part...
What is the current status of trial NCT06355414?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-04-22. Estimated completion is 2026-08-30.
What conditions does trial NCT06355414 study?
This clinical trial studies the following conditions: Depression, Chronic Low Back Pain.
What interventions are being tested in trial NCT06355414?
The interventions under investigation include: Psilocybin (DRUG), Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT06355414?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06355414 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06355414's enrollment target sits among peer trials
40 509th of 679 higher than 151 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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