Psilocybin With Intracranial Neural Sensing (PINS)

Joshua Woolley, MD, PhD

Status and phase: Invitation-only; Phase 1

Conditions: Chronic Pain

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Other

Identifiers

NCT06919640

23-39870

PR#202507H (Other Identifier)

175145 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

10mg oral psilocybin

Experimental group

Treatment:

Drug: Psilocybin