POP: Psilocybin Therapy for Chronic Low Back Pain

Sponsor

Joshua Woolley, MD/PhD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05351541

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain	Drug: Psilocybin therapy with Zolpidem and Modafinil Drug: Psilocybin therapy with Zolpidem Drug: Psilocybin therapy with Modafinil Drug: Psilocybin therapy with Placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

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.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

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psilocybin in combination with zolpidem and modafinil Single dose of Psilocybin (1mg-25mg) in combination with zolpidem and modafinil	Drug: Psilocybin therapy with Zolpidem and Modafinil 1-25 mg (oral administration), Modafinil (oral administration), and Zolpidem (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	Drug: Psilocybin therapy with Zolpidem 1-25 mg (oral administration), Zolpidem (oral administration), and placebo (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	Drug: Psilocybin therapy with Modafinil 1-25 mg (oral administration), Modafinil (oral administration), and placebo (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 with Placebo 1-25 mg (oral administration), and placebo (oral administration) Other Names: 4-phosphoryloxy- N,N-dimethyltryptamine

Outcome Measures

Primary Outcome Measures

Change in pain interference [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

Change in pain interference [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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