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Psilocybin Therapy for Chronic Low Back Pain (POP)

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Psilocybin therapy with Zolpidem and Modafinil
Psilocybin therapy with Zolpidem
Psilocybin therapy with Modafinil
Psilocybin therapy with Placebo
Sponsored by
Joshua Woolley, MD/PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic pain, Psilocybin, Psilocybin Therapy

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Psilocybin in combination with Zolpidem and Modafinil

Psilocybin in combination with Zolpidem

Psilocybin in combination with Modafinil

Psilocybin in combination with Placebo

Arm Description

Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil

Single dose of Psilocybin (1mg-30mg) in combination with zolpidem

Single dose of Psilocybin (1mg-30mg) in combination with modafinil

Single dose of Psilocybin (1mg-30mg) in combination with placebo

Outcomes

Primary Outcome Measures

Change in pain interference
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.

Secondary Outcome Measures

Change in pain interference
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.
Change in average pain intensity
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.
Change in clinical depressive symptom severity
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.
Change in depressive symptom severity
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.

Full Information

First Posted
April 22, 2022
Last Updated
October 12, 2023
Sponsor
Joshua Woolley, MD/PhD
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1. Study Identification

Unique Protocol Identification Number
NCT05351541
Brief Title
Psilocybin Therapy for Chronic Low Back Pain
Acronym
POP
Official Title
A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua Woolley, MD/PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic pain, Psilocybin, Psilocybin Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All patients will receive a dose of psilocybin between 1-30 mg, and one of the following: placebo, zolpidem, modafinial, or zolpidem and modafinil. All patients will receive two psilocybin preparation sessions , a single dose of psilocybin within a therapeutic environment (6-8 hours), three integration sessions and two follow up visits. All drugs will be orally administered during the dosing session. The study procedures will follow best practices for administering psilocybin in clinical trials.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This trial is testing various doses of psilocybin in combination with add-on medications. Participants, study staff and clinical assessors will be blinded to individual treatment conditions until study close-out. The clinician administered instruments will be administered by different clinical study staff than the facilitators who provide the preparation, psilocybin therapy, and integration sessions.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psilocybin in combination with Zolpidem and Modafinil
Arm Type
Experimental
Arm Description
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil
Arm Title
Psilocybin in combination with Zolpidem
Arm Type
Experimental
Arm Description
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem
Arm Title
Psilocybin in combination with Modafinil
Arm Type
Experimental
Arm Description
Single dose of Psilocybin (1mg-30mg) in combination with modafinil
Arm Title
Psilocybin in combination with Placebo
Arm Type
Experimental
Arm Description
Single dose of Psilocybin (1mg-30mg) in combination with placebo
Intervention Type
Drug
Intervention Name(s)
Psilocybin therapy with Zolpidem and Modafinil
Other Intervention Name(s)
4-phosphoryloxy- N,N-dimethyltryptamine
Intervention Description
1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
Intervention Type
Drug
Intervention Name(s)
Psilocybin therapy with Zolpidem
Other Intervention Name(s)
4-phosphoryloxy- N,N-dimethyltryptamine
Intervention Description
1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
Intervention Type
Drug
Intervention Name(s)
Psilocybin therapy with Modafinil
Other Intervention Name(s)
4-phosphoryloxy- N,N-dimethyltryptamine
Intervention Description
1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
Intervention Type
Drug
Intervention Name(s)
Psilocybin therapy with Placebo
Other Intervention Name(s)
4-phosphoryloxy- N,N-dimethyltryptamine
Intervention Description
1-30 mg (oral administration), and placebo (oral administration)
Primary Outcome Measure Information:
Title
Change in pain interference
Description
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.
Time Frame
Baseline, 1-month after psilocybin session
Secondary Outcome Measure Information:
Title
Change in pain interference
Description
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.
Time Frame
Baseline, 1-week, and 3-months
Title
Change in average pain intensity
Description
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.
Time Frame
Baseline, 1-week, 1-month, and 3-months after psilocybin session
Title
Change in clinical depressive symptom severity
Description
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.
Time Frame
Baseline, 1-week, 1-month, and 3-months after psilocybin session
Title
Change in depressive symptom severity
Description
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.
Time Frame
Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Sakai
Phone
415-221-4810
Ext
24074
Email
psilocybinstudies@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Woolley
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber McKernan
Email
psilocybinstudies@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Psilocybin Therapy for Chronic Low Back Pain

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