Psilocybin Therapy for Chronic Lower Back Pain

(POP Trial)

Overseen By Kimberly Sakai

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Joshua Woolley, MD, PhD

Must not be taking: Dopamine agonists, MAO inhibitors

Disqualifiers: Malignancy, Neurologic signs, others

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

Compensation: Varies

Number of Visits: 6

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether psilocybin therapy, a psychedelic treatment, can help people manage chronic lower back pain more effectively. Participants will receive a dose of psilocybin along with one or more other drugs, such as a placebo, zolpidem, or modafinil, and will discuss their experiences in follow-up sessions. The study seeks individuals with chronic lower back pain who have tried at least two treatments without success. Study visits occur at the University of California, San Francisco. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking pain management research.

Will I have to stop taking my current medications?

The trial requires that you do not regularly use medications that might interact with psilocybin, such as dopamine agonists, MAO inhibitors, antipsychotics, and stimulants. If you are on these medications, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin therapy is generally safe when used in a controlled setting. In one study, participants reported no serious side effects after a single dose of psilocybin, suggesting it is safe for short-term use, both physically and mentally.

However, high doses can sometimes cause unwanted effects, such as anxiety or negative experiences. These effects are usually temporary. Studies on psilocybin use for chronic pain have shown that many participants experience significant pain relief.

Overall, while psilocybin is mostly well-tolerated, it is important to use it in a controlled environment with professional guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for chronic lower back pain, which often involve NSAIDs, opioids, or physical therapy, psilocybin therapy offers a completely different approach. Psilocybin, a psychedelic compound, works by altering brain connectivity and perception, potentially addressing pain from a neurological angle rather than just masking the symptoms. Researchers are excited about its potential to offer long-term relief after just a single dose, unlike most current treatments that require continuous use. Additionally, combining psilocybin with agents like zolpidem or modafinil may enhance its effects, providing a unique, multifaceted approach to pain management.

What evidence suggests that this trial's treatments could be effective for chronic lower back pain?

Research has shown that psilocybin therapy might help with chronic pain, such as long-term low back pain. Many individuals who have used psilocybin report significant pain relief. One study found that psilocybin was the most effective psychedelic for improving both physical and mental health related to pain. Another study demonstrated a substantial reduction in pain levels for those who used psilocybin. This trial will test psilocybin in various combinations: with placebo, with zolpidem, with modafinil, and with both zolpidem and modafinil. These findings suggest that psilocybin could be beneficial for managing chronic low back pain. ^{5 6 7 8 9}

Who Is on the Research Team?

Joshua Woolley

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults aged 25-70 with chronic low back pain, who are comfortable in English and can attend sessions at UCSF. They should have tried at least two other treatments without success. It's not for those with pain due to cancer, fractures, infections, or if the pain extends below the knee with neurological signs.

Inclusion Criteria

I am between 25 and 70 years old.

I have been diagnosed with chronic low back pain.

I have tried at least two treatments and physical therapy for my low back pain.

Exclusion Criteria

My chronic low back pain is due to cancer, a recent fracture, or an infection.

I am not taking medication that could interact with psilocybin.

I have low back pain with signs of nerve issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants undergo two preparation sessions before the dosing session

1-2 weeks

2 visits (in-person)

Dosing

Participants receive a single dose of Psilocybin in combination with other drugs

1 day

1 visit (in-person)

Integration

Participants attend three integration sessions to discuss their psilocybin experience

1-2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin Therapy

Trial Overview The study tests psilocybin therapy's effectiveness on chronic low back pain. Participants will receive psilocybin combined with Modafinil, Zolpidem, both drugs or a placebo in various sessions including preparation and follow-ups to discuss their experiences.

How Is the Trial Designed?

Group I: Psilocybin in combination with Zolpidem and Modafinil Experimental Treatment 1 Intervention

Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil

Group II: Psilocybin in combination with Zolpidem Experimental Treatment 1 Intervention

Single dose of Psilocybin (1mg-30mg) in combination with zolpidem

Group III: Psilocybin in combination with Placebo Experimental Treatment 1 Intervention

Single dose of Psilocybin (1mg-30mg) in combination with placebo

Group IV: Psilocybin in combination with Modafinil Experimental Treatment 1 Intervention

Single dose of Psilocybin (1mg-30mg) in combination with modafinil

Who Is Running the Clinical Trial?

Joshua Woolley, MD, PhD

Lead Sponsor

Trials

3

Recruited

100+

Joshua Woolley, MD/PhD

Lead Sponsor

Trials

2

Recruited

40+

Published Research Related to This Trial

In a study of 11 patients with failed back surgery syndrome (FBSS) treated with a combination of THC and CBD alongside spinal cord stimulation (SCS) for 12 months, all patients experienced effective pain management, with significant reductions in pain levels from a baseline average of 8.18 to 4.72 on a numeric rating scale (P<0.001).

The combination of THC and CBD demonstrated sustained analgesic effects throughout the treatment period, indicating that cannabinoid agonists can be a valuable adjunct therapy for managing chronic refractory pain in FBSS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids and spinal cord stimulation for the treatment of failed back surgery syndrome refractory pain. Mondello, E., Quattrone, D., Cardia, L., et al.[2022]

Citations

1. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05351541

NCT05351541 | Psilocybin Therapy for Chronic Low Back ... This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and ...

3. 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 ...

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

Psilocybin as a novel treatment for chronic pain - Askey Data to be reported. Significant reduction in weekly migraine days, significant reduction in pain severity reported for 10 subjects followed ...

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

Preliminary safety and effectiveness of psilocybin-assisted ... Similarly, surveys show that many individuals using psilocybin and other psychedelics for chronic pain report substantial pain relief (34–36). In a North ...

6. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06303-z

Prolonged adverse effects from repeated psilocybin use in an ... High doses of psychedelics have been identified as a risk factor for adverse events in naturalistic studies on PAEs [13]. Additionally, high ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11958999/

Preliminary safety and effectiveness of psilocybin-assisted ... Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: an open-label pilot clinical trial

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

Safety pharmacology of acute psilocybin administration in ... No serious adverse reactions occurred. These findings suggest that a single administration of psilocybin is safe with regard to acute psychological and physical ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06355414

Psilocybin in Chronic Low Back Pain and Depression This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression ...