Enrolling by InvitationPhase 1psilocybin
Psilocybin With Intracranial Neural Sensing
Sponsored by Joshua Woolley, MD, PhD
NCT ID
NCT06919640
Target Enrollment
20 participants
Start Date
2025-06-01
Est. Completion
2028-04-30
About This Study
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.
Conditions Studied
Interventions
- •Psilocybin
Eligibility
Age:21 Years - 75 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Currently implanted chronic brain sensing device (such as RC+S or Percept) * Not currently enrolled in another trial * Ability to speak and read English * Able to attend all in-person and virtual visits * No changes in medication or major surgical procedures anticipated for the trial * Able to identify someone to accompany from the research unit at the end of drug administration day or agreement to have a study team member accompany them from the research unit Exclusion Criteria: * A health condition that makes this study unsafe or unfeasible, determined by study physicians * Use of medication, vitamins, or supplements and unwilling or unable to discontinue medications that have problematic interactions with psilocybin * Adulthood epilepsy or other seizure disorder * Require supplemental oxygen * Medical finding or diagnosis that would make participation in this trial unsafe
Study Locations (1)
University of California, San Francisco
San Francisco, California, United States