Psilocybin With Intracranial Neural Sensing (PINS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Psilocybin

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10mg oral psilocybin	Drug: Psilocybin; 10mg oral psilocybin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in neural functional connectivity	Measured by high-gamma coherence, cross-correlations, and Granger Causality	Drug administration to 90 days following

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective changes in pain	Measured by subjective pain scales	Drug administration to 90 days following

Collaborators and Investigators

• Sponsor: Joshua Woolley, MD, PhD
• Investigators: Principal Investigator: Prasad Shirvalkar, MD/PHD, University of California, San Francisco; Principal Investigator: Joshua Woolley, MD/PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; pain; psilocybin; dbs; psychedelic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Psychotropic Drugs; Hallucinogens; Psilocybin
• Other Study ID Numbers: 23-39870; 175145 (Other Identifier: FDA); PR#202507H (Other Identifier: Research Panel of California)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No