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Active, Not Recruiting

NCT Number: NCT05351541

Psilocybin Therapy for Chronic Low Back Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Low-back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California San Francisco

San Francisco, California, 94107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin therapy with Zolpidem and Modafinil

Drug

1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)

Other names: 4-phosphoryloxy- N,N-dimethyltryptamine

Psilocybin therapy with Zolpidem

Drug

1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)

Other names: 4-phosphoryloxy- N,N-dimethyltryptamine

Psilocybin therapy with Modafinil

Drug

1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)

Other names: 4-phosphoryloxy- N,N-dimethyltryptamine

Psilocybin therapy with Placebo

Drug

1-30 mg (oral administration), and placebo (oral administration)

Other names: 4-phosphoryloxy- N,N-dimethyltryptamine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Joshua Woolley, MD, PhD

Other

Registry information

Official study title

A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain

Acronym: POP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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