Clinical trial NCT05351541: Psilocybin Therapy for Chronic Low Back Pain
Official title: A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Low-back Pain
Keywords: Chronic pain
Psilocybin
Psilocybin Therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will receive a dose of psilocybin between 1-30 mg, and one of the following: placebo, zolpidem, modafinial, or zolpidem and modafinil. All patients will receive two psilocybin preparation sessions , a single dose of psilocybin within a therapeutic environment (6-8 hours), three integration sessions and two follow up visits. All drugs will be orally administered during the dosing session. The study procedures will follow best practices for administering psilocybin in clinical trials.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain interference
timeFrame: Baseline, 1-month after psilocybin session
Secondary outcomes:
measure: Change in pain interference
timeFrame: Baseline, 1-week, and 3-months
measure: Change in average pain intensity
timeFrame: Baseline, 1-week, 1-month, and 3-months after psilocybin session
measure: Change in clinical depressive symptom severity
timeFrame: Baseline, 1-week, 1-month, and 3-months after psilocybin session
measure: Change in depressive symptom severity
timeFrame: Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joshua Woolley
role: PRINCIPAL_INVESTIGATOR
References: