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Enrolling by invitationPhase 1

Psilocybin With Intracranial Neural Sensing

NCT06919640 · PINS · Joshua Woolley, MD, PhD

Closed to entry
Status
Not accepting participants
Phase 1
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in neural functional connectivity

    Measured over Drug administration to 90 days following

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 75 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
University of California, San FranciscoSan FranciscoCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06919640 on ClinicalTrials.gov →

Last updated in the registry 2025-06-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits