ClinicalTrials.gg
Enrolling by invitationNCT06919640PINSUpdated Jun 6, 2025

Psilocybin With Intracranial Neural Sensing

A Phase 1 interventional study of Psilocybin in Chronic Pain, sponsored by Joshua Woolley, MD, PhD. Enrolling by invitation at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Joshua Woolley, MD, PhD · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Pain

Keywords

  • chronic pain
  • psilocybin
  • psychedelic
  • pain
  • dbs
03

In context

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Joshua Woolley, MD, PhD is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    10mg oral psilocybin

    Drug: Psilocybin

Interventions

06

What researchers measure

Primary outcomes

  1. Changes in neural functional connectivity

    Measured by high-gamma coherence, cross-correlations, and Granger Causality

    Time frame: Drug administration to 90 days following

Secondary outcomes

  1. Subjective changes in pain

    Measured by subjective pain scales

    Time frame: Drug administration to 90 days following

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06919640
Lead sponsor
Joshua Woolley, MD, PhD
Responsible party
Joshua Woolley, MD, PhD (Associate Professor, University of California, San Francisco) — Sponsor-investigator
First posted
Apr 9, 2025
Start date
Jun 1, 2025
Primary completion
Apr 30, 2028 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Jun 6, 2025

Study contacts

Joshua Woolley, MD/PhD
principal investigator · University of California, San Francisco
Prasad Shirvalkar, MD/PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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