Summary

Eligibility
for people ages 25-70 (full criteria)
Dates
study started
estimated completion
Principal Investigator
by Joshua Woolley
Headshot of Joshua Woolley
Joshua Woolley

Description

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.

Official Title

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

Details

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.

Keywords

Chronic Low-back Pain Chronic pain Psilocybin Psilocybin Therapy Back Pain Low Back Pain Zolpidem Modafinil N,N-Dimethyltryptamine Psilocybin therapy with Zolpidem and Modafinil Psilocybin therapy with Zolpidem Psilocybin therapy with Modafinil

Eligibility

You can join if…

Open to people ages 25-70

  • 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 CAN'T join 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

Lead Scientist at UCSF

  • Joshua Woolley
    Dr. Josh Woolley is an Associate Professor in Residence in the Department of Psychiatry and Behavioral Sciences at the University of California, San Francisco (UCSF) as well as a staff psychiatrist in Mental Health at the San Francisco Veterans Affairs Medical Center (SFVAMC). He is Board Certified in Psychiatry by the American Board of Psychiatry and Neurology.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Joshua Woolley, MD/PhD
ID
NCT05351541
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated