← Back to Search

Psychedelic

Psilocybin Therapy for Chronic Lower Back Pain (POP Trial)

Phase 1 & 2

Recruiting

Led By Joshua Woolley

Research Sponsored by Joshua Woolley, MD/PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 25 to 70 years old

Has tried at least two previous medications/ procedures and physical therapy trials for low back pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-week, 1-month, and 3-months after psilocybin session

Awards & highlights

POP Trial Summary

This trial will assess if psilocybin therapy helps people manage chronic low back pain. Participants will get doses of psilocybin, along with other drugs, and counseling.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Psilocybin may cause temporary changes in perception, mood swings, dizziness or headaches. Modafinil could lead to insomnia or anxiety while Zolpidem might result in daytime drowsiness or unusual dreams.

POP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 25 and 70 years old.

Select...

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

POP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-week, 1-month, and 3-months after psilocybin session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-week, 1-month, and 3-months after psilocybin session

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week, 1-month, and 3-months after psilocybin session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in average pain intensity

Change in clinical depressive symptom severity

Change in depressive symptom severity

+1 more

POP Trial Design

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joshua Woolley, MD/PhDLead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

Joshua WoolleyPrincipal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to join this experiment?

"To be eligible for the research, participants must suffer from chronic lower back pain and have an age range between 25 to 70. The total number of enrollees required is 30 individuals."

Answered by AI

Is the age cap for this research trial below fifty-five years old?

"To be considered for this trial, participants must have an age between 25 and 70. There are 7 studies involving minors whereas 261 trials focus on elderly patients."

Answered by AI

To what capacity is this trial accommodating participants?

"Affirmative. The data hosted on clinicaltrials.gov corroborates that this medical research, which was first posted on December 1st 2023, is actively looking for participants. Specifically, 30 patients need to be recruiter from a single clinical centre."

Answered by AI

Are there any openings available for people to take part in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting participants, having been published on December 1st 2023 and last updated October 12th 2023. The recruitment process calls for 30 patients from a single medical centre."

Answered by AI