Psilocybin Therapy for Chronic Low Back Pain

NCT05351541 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 20-21441
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic pain; Psilocybin; Psilocybin Therapy

Outcome Measures

Primary Outcomes (1)

• Change in pain interference

  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.

  Baseline, 1-month after psilocybin session

Secondary Outcomes (4)

• Change in pain interference

  Baseline, 1-week, and 3-months

• Change in average pain intensity

  Baseline, 1-week, 1-month, and 3-months after psilocybin session

• Change in clinical depressive symptom severity

  Baseline, 1-week, 1-month, and 3-months after psilocybin session

• Change in depressive symptom severity

  Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session

Study Arms (4)

Psilocybin in combination with Zolpidem and Modafinil

EXPERIMENTAL

Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil

Drug: Psilocybin therapy with Zolpidem and Modafinil

Psilocybin in combination with Zolpidem

EXPERIMENTAL

Single dose of Psilocybin (1mg-30mg) in combination with zolpidem

Drug: Psilocybin therapy with Zolpidem

Psilocybin in combination with Modafinil

EXPERIMENTAL

Single dose of Psilocybin (1mg-30mg) in combination with modafinil

Drug: Psilocybin therapy with Modafinil

Psilocybin in combination with Placebo

EXPERIMENTAL

Single dose of Psilocybin (1mg-30mg) in combination with placebo

Drug: Psilocybin therapy with Placebo

Interventions

Psilocybin therapy with Zolpidem and Modafinil DRUG

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

Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine

Psilocybin in combination with Zolpidem and Modafinil

Psilocybin therapy with Zolpidem DRUG

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

Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine

Psilocybin in combination with Zolpidem

Psilocybin therapy with Modafinil DRUG

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

Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine

Psilocybin in combination with Modafinil

Psilocybin therapy with Placebo DRUG

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

Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine

Psilocybin in combination with Placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joshua Woolley, MD, PhD: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Zolpidem; Modafinil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Joshua Woolley

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: December 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)