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NCT05351541 · ClinicalTrials.gov registry record · Phase 1
Psilocybin Therapy for Chronic Low Back Pain
A Phase 1 study of Chronic Low Back Pain, sponsored by Joshua Woolley, MD, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05351541: Recruiting Phase 1 study of Chronic Low Back Pain, sponsored by Joshua Woolley, MD, PhD.
NCT05351541 is a Phase 1 study of Chronic Low Back Pain that is actively recruiting participants, run by Joshua Woolley, MD, PhD. The registered enrollment target is 30 participants, below the 592-participant average among 71 other Chronic Low Back Pain 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
NCT05351541, a Phase 1 study of Chronic Low Back Pain, is actively recruiting participants, sponsored by Joshua Woolley, MD, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.
Primary Outcome
The Brief Pain Inventory-Interference subscale (BPI) will be used to assess how pain interferes with a variety of daily activities (e.g., walking, lifting, mood, sleep, relationships). Seven items are rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total possible score ranging from 0 to 70. Higher scores represent greater interference from pain.
Conditions Studied
Interventions
- DRUG Psilocybin therapy with Zolpidem and Modafinil
- DRUG Psilocybin therapy with Zolpidem
- DRUG Psilocybin therapy with Modafinil
- DRUG Psilocybin therapy with Placebo
Study Locations (1)
California
- University of California San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2026-04 |
| Phase | Phase 1 |
What NCT05351541 shows while recruiting
NCT05351541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 592-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Chronic Low Back Pain appearing as the primary indexed condition, and to 4 interventions - of which Psilocybin therapy with Zolpidem and Modafinil is the first listed.
NCT05351541 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05351541 about?
NCT05351541 is a clinical study titled "Psilocybin Therapy for Chronic Low Back Pain". This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possi...
What is the current status of trial NCT05351541?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-12-01. Estimated completion is 2026-04.
What conditions does trial NCT05351541 study?
This clinical trial studies the following conditions: Chronic Low Back Pain.
What interventions are being tested in trial NCT05351541?
The interventions under investigation include: Psilocybin therapy with Zolpidem and Modafinil (DRUG), Psilocybin therapy with Zolpidem (DRUG), Psilocybin therapy with Modafinil (DRUG), Psilocybin therapy with Placebo (DRUG).
Who is sponsoring clinical trial NCT05351541?
This trial is sponsored by Joshua Woolley, MD, PhD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05351541 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Low Back Pain
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 NCT05351541's enrollment target sits among peer trials
30 64th of 71 higher than 6 of 71 other Chronic Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Low Back Pain 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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