Psilocybin Therapy for Chronic Low Back Pain

Purpose

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

  • Chronic Low-back Pain

Eligibility

Eligible Ages
Between 25 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Psilocybin in combination with Zolpidem and Modafinil 		Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil
  • Drug: Psilocybin therapy with Zolpidem and Modafinil
    1-30 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-30mg) in combination with zolpidem
  • Drug: Psilocybin therapy with Zolpidem and Modafinil
    1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
    Other names:
    • 4-phosphoryloxy- N,N-dimethyltryptamine
  • Drug: Psilocybin therapy with Zolpidem
    1-30 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-30mg) in combination with modafinil
  • Drug: Psilocybin therapy with Modafinil
    1-30 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-30mg) in combination with placebo
  • Drug: Psilocybin therapy with Placebo
    1-30 mg (oral administration), and placebo (oral administration)
    Other names:
    • 4-phosphoryloxy- N,N-dimethyltryptamine

Recruiting Locations

University of California San Francisco
San Francisco, California 94107
Contact:
Amber McKernan
psilocybinstudies@ucsf.edu

More Details

Status
Recruiting
Sponsor
Joshua Woolley, MD, PhD

Study Contact

Kimberly Sakai
415-221-4810
psilocybinstudies@ucsf.edu

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.