30 Participants Needed

Psilocybin Therapy for Chronic Lower Back Pain

(POP Trial)

KS
Overseen ByKimberly Sakai
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Joshua Woolley, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.

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.

How is psilocybin therapy different from other treatments for chronic lower back pain?

Psilocybin therapy is unique because it involves the use of a psychedelic compound that may alter perception and mood, potentially addressing pain through psychological mechanisms, unlike traditional pain treatments that focus on physical symptoms.12345

Research Team

JW

Joshua Woolley

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.
See 2 more

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.
See 2 more

Timeline

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)

Treatment Details

Interventions

  • Psilocybin Therapy
Trial OverviewThe 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.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Psilocybin in combination with Zolpidem and ModafinilExperimental Treatment1 Intervention
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil
Group II: Psilocybin in combination with ZolpidemExperimental Treatment1 Intervention
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem
Group III: Psilocybin in combination with PlaceboExperimental Treatment1 Intervention
Single dose of Psilocybin (1mg-30mg) in combination with placebo
Group IV: Psilocybin in combination with ModafinilExperimental Treatment1 Intervention
Single dose of Psilocybin (1mg-30mg) in combination with modafinil

Find a Clinic Near You

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+

Findings from Research

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

References

Cannabinoids and spinal cord stimulation for the treatment of failed back surgery syndrome refractory pain. [2022]
A randomized controlled trial of hypnosis compared with biofeedback for adults with chronic low back pain. [2022]
Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial. [2022]
Cannabis Use and Low-Back Pain: A Systematic Review. [2021]
The effect and mechanism of traditional Chinese exercise for chronic low back pain in middle-aged and elderly patients: A systematic review. [2023]