This study is not yet accepting patients

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
completion 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
    Associate Professor, Anesthesia, School of Medicine. Authored (or co-authored) 53 research publications. Research interests: Pain Management · Neuromodulation · Deep Brain Stimulation · Headache · Neuropathic Pain · Spinal Cord Stimulation · Post Stroke Pain · Phantom Limb Pain

Details

Status
not yet accepting patients
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