This open-label, single-arm Phase I trial (n=20) will study the effects of a single 10 mg oral dose of psilocybin on neural activity, pain, and cognition in adults with chronic pain who have implanted brain-sensing deep brain stimulation (DBS) devices.
Conducted by Dr Joshua Woolley and colleagues at the University of California, San Francisco, this pilot study leverages participants’ existing DBS implants to directly monitor brain activity before and after psilocybin administration.
Researchers aim to explore how psilocybin alters functional brain connectivity (how different brain areas communicate), whether it reduces self-reported pain levels, and whether it improves cognitive performance. Participants must be between 21 and 75 years old, fluent in English, and capable of attending all study visits. The study excludes individuals with epilepsy, oxygen dependency, or medications that could interfere with psilocybin. The trial will run until 2028 and is among the first to combine psychedelics with implanted neural sensing technology.
Trial Details
This is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (DBS) devices. Outcomes include multi-site neural recording from previously placed ambulatory sensing-capable DBS devices, quantitative sensory and cognitive testing, and self-reports of pain. We hypothesize that psilocybin will change functional connectivity, decrease clinical and task-based pain reports, and improve cognitive functions.Trial Number NCT06919640
Sponsors & Collaborators
University of California San FranciscoAt UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.