Psilocybin Therapy for Chronic Low Back Pain

This double-blind, randomized trial (n=30) will examine the preliminary efficacy of psilocybin therapy (1-30mg) for people suffering from chronic low back pain.

Conducted by Joshua Woolley, MD/PhD from the University of California, San Francisco, the study aims to determine if psilocybin therapy can enhance patients’ ability to cope with chronic low back pain.

Participants, aged 25 to 70, diagnosed with chronic low back pain and comfortable with English, will undergo various preparation, dosing, integration, and follow-up sessions at UCSF. Each participant will receive a dose of psilocybin, ranging from 1-30 mg, along with one or more additional drugs, including zolpidem, modafinil, or a placebo.

The primary outcome measure will assess the change in pain interference using the Brief Pain Inventory-Interference subscale at baseline and one month after the psilocybin session. Secondary outcome measures will include changes in pain intensity and depressive symptom severity over different time frames. The study is expected to start in December 2023 and conclude in December 2024.

Topic Pain
Compound Psilocybin Placebo
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 01 December 2023
End date 31 December 2024
Phase Phase I Phase II
Design Blinded
Type Interventional
Generation First
Participants 30
Sex All
Age 25- 70
Therapy Yes

Trial Details

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.

NCT Number NCT05351541

Sponsors & Collaborators

University of California San Francisco
At UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.