RECRUITING

Psilocybin Therapy for Chronic Low Back Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-12-01
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05351541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 25 to 70 years old
  2. * Comfortable speaking and writing in English
  3. * Diagnosed with chronic low back pain
  4. * Able to attend all in-person visits at UCSF as well as virtual visits
  5. * Has tried at least two previous medications/ procedures and physical therapy trials for low back pain
  1. * Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection
  2. * Low back pain with radiation below the knee
  3. * Low back pain with neurologic signs present
  4. * Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, antipsychotics, and stimulants
  5. * A health condition that makes study unsafe or unfeasible, determined by study physicians

Contacts and Locations

Study Contact

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

Principal Investigator

Joshua Woolley
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94107
United States

Collaborators and Investigators

Sponsor: Joshua Woolley, MD/PhD

  • Joshua Woolley, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Chronic pain
  • Psilocybin
  • Psilocybin Therapy

Additional Relevant MeSH Terms

  • Chronic Low-back Pain