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Psilocybin Therapy for Chronic Low Back Pain (POP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05351541
Recruitment Status : Not yet recruiting
First Posted : April 28, 2022
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
Joshua Woolley, MD/PhD, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 22, 2022
First Posted Date  ICMJE April 28, 2022
Last Update Posted Date May 4, 2022
Estimated Study Start Date  ICMJE June 2022
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin Therapy for Chronic Low Back Pain
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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  ICMJE Chronic Low-back Pain
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2022)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kimberly Sakai 415-221-4810 ext 24074 psilocybinstudies@ucsf.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05351541
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Joshua Woolley, MD/PhD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joshua Woolley University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP