Psilocybin Therapy for Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

— POP  

Official title:

A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351541
• Other study ID #: 20-21441
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: Kimberly Sakai
• Phone: 415-221-4810
• Email: psilocybinstudies[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. The investigators will determine whether psilocybin therapy improves patients' ability to cope with chronic low back pain. If psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 25 to 70 years old

• Comfortable speaking and writing in English

• Diagnosed with chronic low back pain

• Able to attend all in-person visits at UCSF as well as virtual visits

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

Exclusion Criteria:

• Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection

• Low back pain with radiation below the knee

• Low back pain with neurologic signs present

• Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, antipsychotics, and stimulants

• A health condition that makes study unsafe or unfeasible, determined by study physicians

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Drug:
• Psilocybin therapy with Zolpidem and Modafinil
1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
• Psilocybin therapy with Zolpidem
1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
• Psilocybin therapy with Modafinil
1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
• Psilocybin therapy with Placebo
1-30 mg (oral administration), and placebo (oral administration)

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Joshua Woolley, MD/PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain interference	The Brief Pain Inventory-Interference subscale (BPI) will be used to assess how pain interferes with a variety of daily activities (e.g., walking, lifting, mood, sleep, relationships). Seven items are rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total possible score ranging from 0 to 70. Higher scores represent greater interference from pain.	Baseline, 1-month after psilocybin session
Secondary	Change in pain interference	The Brief Pain Inventory-Interference subscale (BPI) will be used to assess how pain interferes with a variety of daily activities (e.g., walking, lifting, mood, sleep, relationships). Seven items are rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total possible score ranging from 0 to 70. Higher scores represent greater interference from pain.	Baseline, 1-week, and 3-months
Secondary	Change in average pain intensity	The Brief Pain Inventory with the Michigan Body Map will be used to assess pain location and worst, least, average, and present pain on a numerical rating scale from 0 (no pain) to 10 (pain as bad as you can imagine) over the past 24 hours, where higher scores represent greater pain intensity.	Baseline, 1-week, 1-month, and 3-months after psilocybin session
Secondary	Change in clinical depressive symptom severity	The 17-item clinician administered Hamilton Rating Scale for Depression will be used to assess changes in the severity of depressive symptoms. Each item is scored by a clinician on a 3- or 5-point scale from 0 (Not present) to 4 (severe) and summed for a total score between 0 and 52. A higher total score represents greater depressive symptom severity.	Baseline, 1-week, 1-month, and 3-months after psilocybin session
Secondary	Change in depressive symptom severity	The 7-item PROMIS-Depression self-report scale will be used as an additional indicator for changes in depression symptom severity. Items are endorsed on a 5-point scale ranging from 1 (Never) to 5 (Always). A higher total score represents greater depressive symptom severity.	Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session