Psilocybin for Chronic Pain

(PINS Trial)

Overseen By Kimberly Sakai

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Joshua Woolley, MD, PhD

Must not be taking: Psilocybin interactions

Disqualifiers: Epilepsy, Seizure disorder, Oxygen, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests psilocybin, a compound found in some mushrooms, to determine its potential to help people with chronic pain. Researchers aim to assess whether psilocybin affects brain activity, reduces pain, and improves cognitive skills in individuals with an implanted brain device that can monitor these changes. The trial seeks participants with a sensing-capable deep brain stimulation device who are not currently enrolled in another trial. Participants must attend all study visits and have someone accompany them after taking psilocybin. As a Phase 1 trial, this research focuses on understanding how psilocybin works in people, offering participants the opportunity to be among the first to receive this treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with psilocybin. The study requires participants to discontinue medications that have problematic interactions with psilocybin.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Studies have shown that psilocybin, when used in a controlled setting, is generally safe. Some people might experience temporary side effects, but these are usually mild. Research suggests that psilocybin can help reduce pain and improve mental health for some individuals. While it appears promising for treating pain and depression, its overall safety for these uses remains under investigation. This trial represents an early step in exploring psilocybin's potential for managing chronic pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for chronic pain, which often include opioids or non-steroidal anti-inflammatory drugs (NSAIDs), psilocybin is derived from psychedelic mushrooms and offers a novel approach by potentially altering the brain's perception of pain. Researchers are excited about psilocybin because it works on serotonin receptors, which are not typically targeted by conventional pain medications. This unique mechanism could lead to new ways of managing chronic pain without the risk of addiction associated with opioids. Additionally, psilocybin may provide lasting relief after just a few doses, which is a significant departure from the continuous use required by current pain medications.

What evidence suggests that psilocybin might be an effective treatment for chronic pain?

Research shows that psilocybin, a substance found in certain mushrooms, might help ease chronic pain. One study identified psilocybin as the most effective psychedelic for improving both physical and mental health. Animal studies found that just one dose can lessen pain from nerve injuries and inflammation. Psilocybin likely works by affecting brain areas involved in pain, possibly leading to long-lasting improvements. It may also support neuroplasticity, the brain's ability to change and adapt, aiding in better pain management. These findings suggest psilocybin could be a promising option for treating chronic pain. Participants in this trial will receive a 10mg oral dose of psilocybin to further investigate its potential benefits for chronic pain. ^{2 4 5 6 7}

Who Is on the Research Team?

Joshua Woolley, MD/PhD

Principal Investigator

University of California, San Francisco

Prasad Shirvalkar, MD/PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with chronic pain who already have deep brain stimulation (DBS) devices implanted that can record neural activity. Participants should be interested in taking a single dose of psilocybin to see how it affects their pain and cognitive functions.

Inclusion Criteria

I don't expect to change my medications or have major surgery during the trial.

Not currently enrolled in another trial

Ability to speak and read English

Exclusion Criteria

I have epilepsy or another seizure disorder.

I need extra oxygen.

Medical finding or diagnosis that would make participation in this trial unsafe

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single, medium dose of psilocybin and undergo neural, sensory, and cognitive testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in neural functional connectivity, pain, and cognitive functions

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests the effects of a medium dose of psilocybin on patients with chronic pain who have sensing-capable DBS devices. It's an open-label, pilot study focusing on changes in brain connectivity, pain perception, and cognitive improvements.

How Is the Trial Designed?

Group I: 10mg oral psilocybin Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Joshua Woolley, MD, PhD

Lead Sponsor

Trials

3

Recruited

100+

Published Research Related to This Trial

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11811946/

Psychedelics and chronic pain: self-reported outcomes on ... Psilocybin was reported as the most effective psychedelic in treating both physical (29.4%; n = 137/466), and mental (48.9%; n = 133/270) health ...

2. pennmedicine.org pennmedicine.org/news/psilocybin-targets-brain-circuits-to-relieve-pain

Psilocybin targets brain circuits to relieve pain In studies using mice with chronic nerve injury and inflammatory pain, researchers found that a single dose of psilocybin reduced both pain and ...

3. nature.com nature.com/articles/s41593-025-02068-0

Single-dose psilocybin rapidly and sustainably relieves ... Here, in two chronic pain models, we show that a single dose of psilocybin induces a rapid and sustained reversal of both mechanical allodynia ...

4. bpspubs.onlinelibrary.wiley.com bpspubs.onlinelibrary.wiley.com/doi/10.1111/bph.17420

Psilocybin as a novel treatment for chronic pain - Askey By promoting neuroplasticity, psilocybin could provide long-lasting improvements in pain-related affective and sensory dysfunction in ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05351541

Psilocybin Therapy for Chronic Low Back Pain This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively.

6. sciencedirect.com sciencedirect.com/science/article/pii/S277240852400125X

Safety pharmacology of acute psilocybin administration in ... The results of this study indicate that psilocybin appears to be safe in a controlled setting with transient adverse effects. The safety data can partially be ...

7. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2025.1527783/full

Preliminary safety and effectiveness of psilocybin-assisted ... Survey studies have reported that a number of people using psilocybin and other psychedelics for a range of chronic pain conditions often report decreased pain ...