This study is accepting new patients by invitation only

Psilocybin With Intracranial Neural Sensing

a study on Pain Psilocybin

Summary

Eligibility
for people ages 21-75 (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Joshua Woolley, MD/PhDPrasad Shirvalkar, MD/PhD
Headshot of Joshua Woolley
Joshua Woolley
Headshot of Prasad Shirvalkar
Prasad Shirvalkar

Description

Summary

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.

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.

Keywords

Chronic Pain, psilocybin, psychedelic, pain, dbs

Eligibility

You can join if…

Open to people ages 21-75

  • 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

You CAN'T join if...

  • 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

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientists at UCSF

  • Joshua Woolley, MD/PhD
    Dr. Josh Woolley is an Associate Professor in Residence in the Department of Psychiatry and Behavioral Sciences at the University of California, San Francisco (UCSF) as well as a staff psychiatrist in Mental Health at the San Francisco Veterans Affairs Medical Center (SFVAMC). He is Board Certified in Psychiatry by the American Board of Psychiatry and Neurology.
  • Prasad Shirvalkar, MD/PhD
    Dr. Prasad Shirvalkar is a neurologist and interventional pain medicine specialist who provides the full spectrum of care for chronic pain conditions. This includes conservative, nonsurgical treatments such as medications and nerve blocks.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Joshua Woolley, MD, PhD
ID
NCT06919640
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated