Psilocybin therapy for chronic low back pain relief
A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
This study is testing if psilocybin therapy can help people with chronic low back pain manage their discomfort better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05351541 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of psilocybin therapy in helping patients manage chronic low back pain. Participants will receive psilocybin along with other medications, and will engage in preparation, dosing, and integration sessions to discuss their experiences. The goal is to determine if psilocybin can improve coping mechanisms for chronic pain, potentially leading to new treatment options for this condition. The study will take place at the University of California San Francisco (UCSF).
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 70 with a diagnosis of chronic low back pain who have not found relief from previous treatments.
Not a fit: Patients with low back pain due to malignancy, fractures, infections, or those with significant neurological signs may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel approach to managing chronic low back pain and improve patients' quality of life.
How similar studies have performed: Previous studies have shown positive outcomes with psilocybin therapy for various psychological conditions, but its application for chronic pain is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Woolley — University of California, San Francisco
- Study coordinator: Kimberly Sakai
- Email: psilocybinstudies@ucsf.edu
- Phone: 415-221-4810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.