Psilocybin With Intracranial Neural Sensing

NCT06919640 | Enrolling By Invitation Phase 1 FDA Drug

• 3 other identifiers: 23-39870175145PR#202507H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

chronic pain; psilocybin; psychedelic; pain; dbs

Outcome Measures

Primary Outcomes (1)

• Changes in neural functional connectivity

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

  Drug administration to 90 days following

Secondary Outcomes (1)

• Subjective changes in pain

  Drug administration to 90 days following

Study Arms (1)

10mg oral psilocybin

EXPERIMENTAL

Drug: Psilocybin

Interventions

Psilocybin DRUG

10mg oral psilocybin

10mg oral psilocybin

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Joshua Woolley, MD, PhD: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Joshua Woolley, MD/PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Prasad Shirvalkar, MD/PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)