Psilocybin Therapy for Chronic Low Back Pain

Psilocybin

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.

Intervention / Treatment

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.
  • Psilocybin therapy with Zolpidem and Modafinil (DRUG)
    1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
  • Psilocybin therapy with Zolpidem (DRUG)
    1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
  • Psilocybin therapy with Modafinil (DRUG)
    1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
  • Psilocybin therapy with Placebo (DRUG)
    1-30 mg (oral administration), and placebo (oral administration)

Condition or Disease

  • Chronic Low-back Pain

Phase

  • Phase 1
  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Age: 25 Years to 70 Years
    Enrollment: 30 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    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.

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2023 ESTIMATED
    Primary Completion: Dec 01, 2024 ESTIMATED
    Completion Date: Dec 01, 2024 ESTIMATED
    Study First Posted: Apr 28, 2022 ACTUAL
    Last Updated: Aug 22, 2023

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    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.

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 25
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 Outcomes

    • 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.

    • 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.

    • 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.

    • 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.

    More Details

    NCT Number: NCT05351541
    Acronym: POP
    Other IDs: 20-21441
    Study URL: https://clinicaltrials.gov/study/NCT05351541
    Last updated: Sep 29, 2023