Clinical trial NCT06919640: Psilocybin With Intracranial Neural Sensing
Official title: Psilocybin With Intracranial Neural Sensing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Chronic Pain
Keywords: chronic pain
psilocybin
psychedelic
pain
dbs
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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: 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.

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

Primary outcomes:
measure: Changes in neural functional connectivity
timeFrame: Drug administration to 90 days following
Secondary outcomes:
measure: Subjective changes in pain
timeFrame: Drug administration to 90 days following
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joshua Woolley, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Prasad Shirvalkar, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: