Psilocybin Therapy for Chronic Low Back Pain
Active, not recruitingPhase 1, Phase 2NCT05351541
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
- Conditions
- Interventions
- Drug: Psilocybin therapy with Zolpidem and Modafinil
- Drug: Psilocybin therapy with Zolpidem
- Drug: Psilocybin therapy with Modafinil
- Drug: Psilocybin therapy with Placebo
- Sponsor
- Joshua Woolley, MD, PhD
- Organization
- University of California, San Francisco
- Start date
- 2023-12-01
- Primary completion
- 2026-07
- Sex
- All
- Age range
- from 25 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05351541