Psilocybin With Intracranial Neural Sensing | NCT06919640

Studies
Psilocybin With Intracranial Neural Sensing

NCT06919640

Sponsor

Joshua Woolley, MD, PhD

Status

Enrolling by invitation

Last Update Posted

Jun 6, 2025Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Chronic Pain

Interventions

Psilocybin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
175145	Other Identifier	FDA
PR#202507H	Other Identifier	Research Panel of California

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Apr 30, 2028Estimated

Completion Date

Apr 30, 2028Estimated

First Submitted Date

Apr 2, 2025

First Submission Date that Met QC Criteria

Apr 2, 2025

First Posted Date

Apr 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2025

Last Update Posted Date

Jun 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
10mg oral psilocybin	Experimental		Drug: Psilocybin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psilocybin	Drug	10mg oral psilocybin	10mg oral psilocybin

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joshua Woolley, MD/PhD	University of California, San Francisco	Principal Investigator
Prasad Shirvalkar, MD/PhD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011562	Psilocybin

Ancestor Terms

ID	Term
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles

Browse Leaves

Not provided

Browse Branches

Not provided