Psilocybin Therapy for Chronic Low Back Pain (POP)

• ClinicalTrials.gov Identifier: NCT05351541
• Recruitment Status: Not yet recruiting
• First Posted: April 28, 2022
• Last Update Posted: May 4, 2022
• Sponsor: Joshua Woolley, MD/PhD
• Information provided by (Responsible Party): Joshua Woolley, MD/PhD, University of California, San Francisco

Tracking Information

• First Submitted Date: April 22, 2022
• First Posted Date: April 28, 2022
• Last Update Posted Date: May 4, 2022
• Estimated Study Start Date: June 2022
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 22, 2022)

• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Psilocybin Therapy for Chronic Low Back Pain
• Official Title: A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose: Treatment

• Condition: Chronic Low-back Pain

Intervention

• Drug: Psilocybin therapy with Zolpidem and Modafinil
  1-25 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
  Other Name: 4-phosphoryloxy- N,N-dimethyltryptamine
• Drug: Psilocybin therapy with Zolpidem
  1-25 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
  Other Name: 4-phosphoryloxy- N,N-dimethyltryptamine
• Drug: Psilocybin therapy with Modafinil
  1-25 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
  Other Name: 4-phosphoryloxy- N,N-dimethyltryptamine
• Drug: Psilocybin therapy with Placebo
  1-25 mg (oral administration), and placebo (oral administration)
  Other Name: 4-phosphoryloxy- N,N-dimethyltryptamine

Study Arms

• Experimental: Psilocybin in combination with zolpidem and modafinil
  Single dose of Psilocybin (1mg-25mg) in combination with zolpidem and modafinil
  Intervention: Drug: Psilocybin therapy with Zolpidem and Modafinil
• Experimental: Psilocybin in combination with zolpidem
  Single dose of Psilocybin (1mg-25mg) in combination with zolpidem
  Intervention: Drug: Psilocybin therapy with Zolpidem
• Experimental: Psilocybin in combination with modafinil
  Single dose of Psilocybin (1mg-25mg) in combination with modafinil
  Intervention: Drug: Psilocybin therapy with Modafinil
• Experimental: Psilocybin in combination with placebo
  Single dose of Psilocybin (1mg-25mg) in combination with placebo
  Intervention: Drug: Psilocybin therapy with Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 22, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kimberly Sakai; 415-221-4810 ext 24074; psilocybinstudies@ucsf.edu

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05351541
• Other Study ID Numbers: 20-21441
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Joshua Woolley, MD/PhD, University of California, San Francisco
• Original Responsible Party: Same as current
• Current Study Sponsor: Joshua Woolley, MD/PhD
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of California, San Francisco
• Verification Date: April 2022