Psilocybin Therapy for Chronic Low Back Pain (POP)

January 2, 2024 updated by: Joshua Woolley, MD/PhD

A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. The investigators will determine whether psilocybin therapy improves patients' ability to cope with chronic low back pain. If psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 25 to 70 years old
  • Comfortable speaking and writing in English
  • Diagnosed with chronic low back pain
  • Able to attend all in-person visits at UCSF as well as virtual visits
  • Has tried at least two previous medications/ procedures and physical therapy trials for low back pain

Exclusion Criteria:

  • Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection
  • Low back pain with radiation below the knee
  • Low back pain with neurologic signs present
  • Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, antipsychotics, and stimulants
  • A health condition that makes study unsafe or unfeasible, determined by study physicians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psilocybin in combination with Zolpidem and Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil
Drug: Psilocybin therapy with Zolpidem and Modafinil
1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
Other Names:
  • 4-phosphoryloxy- N,N-dimethyltryptamine
Experimental: Psilocybin in combination with Zolpidem
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem
Drug: Psilocybin therapy with Zolpidem
1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
Other Names:
  • 4-phosphoryloxy- N,N-dimethyltryptamine
Experimental: Psilocybin in combination with Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with modafinil
Drug: Psilocybin therapy with Modafinil
1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
Other Names:
  • 4-phosphoryloxy- N,N-dimethyltryptamine
Experimental: Psilocybin in combination with Placebo
Single dose of Psilocybin (1mg-30mg) in combination with placebo
Drug: Psilocybin therapy with Placebo
1-30 mg (oral administration), and placebo (oral administration)
Other Names:
  • 4-phosphoryloxy- N,N-dimethyltryptamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain interference
Time Frame: Baseline, 1-month after psilocybin session
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.
Baseline, 1-month after psilocybin session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain interference
Time Frame: Baseline, 1-week, and 3-months
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.
Baseline, 1-week, and 3-months
Change in average pain intensity
Time Frame: Baseline, 1-week, 1-month, and 3-months after psilocybin session
The Brief Pain Inventory with the Michigan Body Map will be used to assess pain location and worst, least, average, and present pain on a numerical rating scale from 0 (no pain) to 10 (pain as bad as you can imagine) over the past 24 hours, where higher scores represent greater pain intensity.
Baseline, 1-week, 1-month, and 3-months after psilocybin session
Change in clinical depressive symptom severity
Time Frame: Baseline, 1-week, 1-month, and 3-months after psilocybin session
The 17-item clinician administered Hamilton Rating Scale for Depression will be used to assess changes in the severity of depressive symptoms. Each item is scored by a clinician on a 3- or 5-point scale from 0 (Not present) to 4 (severe) and summed for a total score between 0 and 52. A higher total score represents greater depressive symptom severity.
Baseline, 1-week, 1-month, and 3-months after psilocybin session
Change in depressive symptom severity
Time Frame: Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session
The 7-item PROMIS-Depression self-report scale will be used as an additional indicator for changes in depression symptom severity. Items are endorsed on a 5-point scale ranging from 1 (Never) to 5 (Always). A higher total score represents greater depressive symptom severity.
Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua Woolley, MD/PhD

Investigators

  • Principal Investigator: Joshua Woolley, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-21441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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