Clinical TrialChronic PainPsilocybinEnrolling by invitation

Psilocybin With Intracranial Neural Sensing (PINS)

Open-label, single-arm Phase I pilot (n=20) assessing a single 10 mg oral dose of psilocybin in adults with chronic pain who have implanted sensing-capable DBS devices; neural, sensory, and cognitive effects measured.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This open-label, single-arm pilot study investigates neural, sensory, and cognitive effects of a single 10 mg oral dose of psilocybin in participants with chronic pain who already have implanted sensing-capable deep brain stimulation devices.

Outcomes include multi-site neural recording from ambulatory DBS devices, quantitative sensory and cognitive testing, and self-reported pain; hypotheses are changes in functional connectivity, reductions in clinical and task-based pain, and improved cognition.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

10 mg psilocybin

experimental

Single oral 10 mg psilocybin in patients with sensing-capable DBS devices.

Interventions

  • Psilocybin10 mg
    via Oral• single dose• 1 doses total

    Single medium oral dose (10 mg).

Participants

Ages
21 – 75
Sexes
Male & Female

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 Details

  • Status
    Enrolling by invitation
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2025-05-01
    End: 2028-04-30
  • Compound
    Psilocybin
  • Topic
    Chronic Pain

Locations

University of California, San Francisco — San Francisco, California, United States

Your Library