Chronic PainPhase 1PINSNCT06919640
Psilocybin With Intracranial Neural Sensing
A Phase 1 study testing Psilocybin in people with Chronic Pain, run by Joshua Woolley, MD, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 30 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Psilocybin
- Keywords
- chronic pain, psilocybin, psychedelic, pain, dbs
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
10mg oral psilocybin
| Study group | Role | What they receive |
|---|---|---|
| 10mg oral psilocybin | Experimental | Not described Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neural functional connectivity
Measured by high-gamma coherence, cross-correlations, and Granger Causality
Measured: Drug administration to 90 days following
Secondary outcomes (1)
Subjective changes in pain
Measured by subjective pain scales
Measured: Drug administration to 90 days following
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jun 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Woolley, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Woolley, MD, PhD, University of California, San Francisco
- Investigators
- Joshua Woolley, MD/PhD, Principal investigator, University of California, San FranciscoPrasad Shirvalkar, MD/PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919640
- Sponsor's protocol ID
- 23-39870
- Other IDs
- 175145, PR#202507H
- Acronym
- PINS
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin With Intracranial Neural Sensing
- ClinicalTrials.gov ID
- NCT06919640
- Acronym / sponsor ID
- PINS / 23-39870
- Conditions
- Chronic Pain
- Keywords
- chronic pain, psilocybin, psychedelic, pain, dbs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Joshua Woolley, MD, PhDUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10mg oral psilocybin | Experimental | Drug: Psilocybin |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin10mg oral psilocybin | Drug | 10mg oral psilocybin |
Primary outcome
Changes in neural functional connectivity
Time frame: Drug administration to 90 days following
Measured by high-gamma coherence, cross-correlations, and Granger Causality
1 secondary outcome
Subjective changes in pain
Time frame: Drug administration to 90 days following
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Woolley, MD/PhD principal investigator
University of California, San Francisco
Prasad Shirvalkar, MD/PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Chronic Pain, run by Joshua Woolley, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neural functional connectivity (time frame: Drug administration to 90 days following). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.