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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 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.

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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.

Conditions Studied

Depression Chronic Low Back Pain

Interventions

  • DRUG Psilocybin
  • DRUG Methylphenidate

Study Locations (1)

Maryland

  • Johns Hopkins University School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-04-22
Est. Completion 2026-08-30
Phase Phase 1

Sponsor

Johns Hopkins University

1,448 total trials

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What the Registry Record Tells You About NCT06355414

The ClinicalTrials.gov registry entry for NCT06355414 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.