drugset / Trial / NCT05351541

Psilocybin Therapy for Chronic Low Back Pain

NCT05351541

Phase 1/2 Active not recruiting 30 enrolled Joshua Woolley, MD, PhD
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2023-12-01
Primary completion
2026-07
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Modafinil Small molecule Oral
Subject Psilocybin Other / unclassified 1 mg Oral
Subject Psilocybin Other / unclassified 30 mg Oral
Subject Zolpidem Small molecule Oral

Indications