Chronic Pain
Conditions
Keywords
chronic pain, psilocybin, psychedelic, pain, dbs
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.
Interventions
DRUGPsilocybin
10mg oral psilocybin
Sponsors
Joshua Woolley, MD, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in neural functional connectivity | Drug administration to 90 days following | Measured by high-gamma coherence, cross-correlations, and Granger Causality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective changes in pain | Drug administration to 90 days following | Measured by subjective pain scales |
Countries
United States
Outcome results
None listed