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

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 (Clinical Trial)
• Estimated 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.
• 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
• Estimated Study Start Date: June 2022
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 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 Name: 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 Name: 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 Name: 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 Name: 4-phosphoryloxy- N,N-dimethyltryptamine

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Joshua Woolley, MD/PhD

Investigators

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

More Information

• Responsible Party: Joshua Woolley, MD/PhD, Associate Professor, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05351541
• Other Study ID Numbers: 20-21441
• First Posted: April 28, 2022
• Last Update Posted: May 4, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Keywords provided by Joshua Woolley, MD/PhD, University of California, San Francisco:

Chronic pain; Psilocybin; Psilocybin Therapy

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Zolpidem; Modafinil; Psilocybin; N,N-Dimethyltryptamine; Central Nervous System Stimulants; Physiological Effects of Drugs; Wakefulness-Promoting Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Central Nervous System Depressants; GABA-A Receptor Agonists; GABA Agonists; GABA Agents; Neurotransmitter Agents; Hallucinogens; Psychotropic Drugs; Serotonin Antagonists; Serotonin Agents; Serotonin Receptor Agonists