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

20 Participants Needed

Trial Summary

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.

What evidence supports the effectiveness of the drug psilocybin for chronic pain?

Some early research suggests that psilocybin, a compound found in psychedelic mushrooms, may help reduce chronic pain. In a small case series, individuals using low doses of psilocybin reported significant pain relief and reduced reliance on traditional pain medications. Additionally, psychedelics like psilocybin have shown promise in altering pain perception and improving quality of life in other conditions, such as depression and anxiety. ^{1 2 3 4 5}

Is psilocybin safe for humans?

Psilocybin, when used in low doses, has shown minimal cognitive or physical side effects in some cases of chronic pain management. However, more research is needed to fully understand its safety and effects in humans. ^{1 2 3 6 7}

How does the drug psilocybin differ from other treatments for chronic pain?

Psilocybin is unique because it may provide pain relief at low doses without causing a psychedelic experience, unlike traditional pain medications that often have significant side effects or risk of addiction. It works by altering pain perception through serotonin receptors and may have long-lasting effects after limited dosing, which is not typical for conventional treatments. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Research Team

Joshua Woolley, MD/PhD

Principal Investigator

University of California, San Francisco

Prasad Shirvalkar, MD/PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Microdosing psilocybin for chronic pain: a case series. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Psychedelics for Pain: A Scoping Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Are psychedelics the answer to chronic pain: A review of current literature. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Are psychedelic medicines the reset for chronic pain? Preliminary findings and research needs. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Potential analgesic effects of psychedelics on select chronic pain conditions: A survey study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Psychedelics as preventive treatment in headache and chronic pain disorders. [2022]