RecruitingPhase 1psilocybin

Psilocybin Therapy for Chronic Low Back Pain

NCT ID

NCT05351541

Target Enrollment

30 participants

Start Date

2023-12-01

Est. Completion

2026-04

About This Study

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.

Conditions Studied

Chronic Low-back Pain

Interventions

•Psilocybin therapy with Zolpidem and Modafinil
•Psilocybin therapy with Zolpidem
•Psilocybin therapy with Modafinil
•Psilocybin therapy with Placebo

Eligibility

Age:25 Years - 70 Years

Healthy Volunteers:No

View full eligibility 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

Study Locations (1)

University of California San Francisco