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History of Changes for Study: NCT05351541
Psilocybin Therapy for Chronic Low Back Pain (POP)
Latest version (submitted April 27, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 22, 2022 None (earliest Version on record)
2 April 27, 2022 Arms and Interventions and Study Status
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Study NCT05351541
Submitted Date:  April 22, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20-21441
Brief Title: Psilocybin Therapy for Chronic Low Back Pain (POP)
Official Title: A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2022
Overall Status: Not yet recruiting
Study Start: June 2022
Primary Completion: December 2024 [Anticipated]
Study Completion: December 2024 [Anticipated]
First Submitted: April 22, 2022
First Submitted that
Met QC Criteria:
April 22, 2022
First Posted: April 28, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
April 22, 2022
Last Update Posted: April 28, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Joshua Woolley, MD/PhD
Responsible Party: Sponsor-Investigator
Investigator: Joshua Woolley, MD/PhD
Official Title: Associate Professor
Affiliation: University of California, San Francisco
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Chronic Low-back Pain
Keywords: Chronic pain
Psilocybin
Psilocybin Therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
All patients will receive a dose of psilocybin between 1-25 mg and up to one or more other drugs (zolpidem and/or 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.
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Psilocybin in combination with zolpidem and modafinil
Single dose of Psilocybin (1mg-25mg) in combination with zolpidem (10mg) and modafinil (200mg)
Drug: Psilocybin therapy
1-25 mg, oral administration
Other Names:
  • 4-phosphoryloxy- N,N-dimethyltryptamine
Experimental: Psilocybin in combination with zolpidem
Single dose of Psilocybin (1mg-25mg) in combination with zolpidem (10mg)
Drug: Psilocybin therapy
1-25 mg, oral administration
Other Names:
  • 4-phosphoryloxy- N,N-dimethyltryptamine
Experimental: Psilocybin in combination with modafinil
Single dose of Psilocybin (1mg-25mg) in combination with modafinil (200mg)
Drug: Psilocybin therapy
1-25 mg, oral administration
Other Names:
  • 4-phosphoryloxy- N,N-dimethyltryptamine
Experimental: Psilocybin in combination with placebo
Single dose of Psilocybin (1mg-25mg) in combination with placebo
Drug: Psilocybin therapy
1-25 mg, oral administration
Other Names:
  • 4-phosphoryloxy- N,N-dimethyltryptamine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. 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.
2. 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.
3. 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.
4. 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.
Open or close this module Eligibility
Minimum Age: 25 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Kimberly Sakai
Telephone: 415-221-4810 Ext. 24074
Email: psilocybinstudies@ucsf.edu
Study Officials: Joshua Woolley
Principal Investigator
University of California, San Francisco
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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