Psilocybin Therapy for Chronic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Psilocybin as a Treatment for Chronic Pain in Smokers

NCT07118332

Smokers With Chronic Pain

NOT_YET_RECRUITING EARLY_PHASE1

Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia

NCT05128162

Fibromyalgia

COMPLETED PHASE2

Psilocybin-facilitated Treatment for Chronic Pain

NCT05068791

Fibromyalgia, Primary

RECRUITING EARLY_PHASE1

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

NCT06731335

Chronic Neuropathic Pain Pain Management

RECRUITING PHASE2

Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action

NCT05548075

Fibromyalgia

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low-back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This trial is testing various doses of psilocybin in combination with add-on medications. Participants, study staff and clinical assessors will be blinded to individual treatment conditions until study close-out. The clinician administered instruments will be administered by different clinical study staff than the facilitators who provide the preparation, psilocybin therapy, and integration sessions.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Psilocybin in combination with Zolpidem and Modafinil

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

Group Type EXPERIMENTAL

Psilocybin therapy with Zolpidem and Modafinil

Intervention Type DRUG

1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)

Psilocybin in combination with Zolpidem

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

Group Type EXPERIMENTAL

Psilocybin therapy with Zolpidem

Intervention Type DRUG

1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)

Psilocybin in combination with Modafinil

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

Group Type EXPERIMENTAL

Psilocybin therapy with Modafinil

Intervention Type DRUG

1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)

Psilocybin in combination with Placebo

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

Group Type EXPERIMENTAL

Psilocybin therapy with Placebo

Intervention Type DRUG

1-30 mg (oral administration), and placebo (oral administration)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psilocybin therapy with Zolpidem and Modafinil

1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)

Intervention Type DRUG

Psilocybin therapy with Zolpidem

1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)

Intervention Type DRUG

Psilocybin therapy with Modafinil

1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)

Intervention Type DRUG

Psilocybin therapy with Placebo

1-30 mg (oral administration), and placebo (oral administration)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

4-phosphoryloxy- N,N-dimethyltryptamine 4-phosphoryloxy- N,N-dimethyltryptamine 4-phosphoryloxy- N,N-dimethyltryptamine 4-phosphoryloxy- N,N-dimethyltryptamine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No