Chronic Low-back PainPhase 1/2POPNCT05351541
Psilocybin Therapy for Chronic Low Back Pain
A Phase 1/2 study testing Psilocybin therapy with Zolpidem and Modafinil, Psilocybin therapy with Zolpidem and Psilocybin therapy with Modafinil in people with Chronic Low-back Pain, run by Joshua Woolley, MD, PhD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Psilocybin therapy with Zolpidem and Modafinil, Psilocybin therapy with Zolpidem and Psilocybin therapy with Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94107
About this study
Official title: A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Psilocybin therapy with Zolpidem and Modafinil, Psilocybin therapy with Zolpidem, Psilocybin therapy with Modafinil, Psilocybin therapy with Placebo
- Keywords
- Chronic pain, Psilocybin, Psilocybin Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin therapy with Zolpidem and ModafinilDrug
Also called 4-phosphoryloxy- N,N-dimethyltryptamine
1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
Psilocybin therapy with ZolpidemDrug
Also called 4-phosphoryloxy- N,N-dimethyltryptamine
1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
Psilocybin therapy with ModafinilDrug
Also called 4-phosphoryloxy- N,N-dimethyltryptamine
1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
Psilocybin therapy with PlaceboDrug
Also called 4-phosphoryloxy- N,N-dimethyltryptamine
1-30 mg (oral administration), and placebo (oral administration)
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin in combination with Zolpidem and Modafinil | Experimental | Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil Receives: Drug: Psilocybin therapy with Zolpidem and Modafinil |
| Psilocybin in combination with Zolpidem | Experimental | Single dose of Psilocybin (1mg-30mg) in combination with zolpidem Receives: Drug: Psilocybin therapy with Zolpidem |
| Psilocybin in combination with Modafinil | Experimental | Single dose of Psilocybin (1mg-30mg) in combination with modafinil Receives: Drug: Psilocybin therapy with Modafinil |
| Psilocybin in combination with Placebo | Experimental | Single dose of Psilocybin (1mg-30mg) in combination with placebo Receives: Drug: Psilocybin therapy with Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1-month after psilocybin session
Secondary outcomes (4)
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.
Measured: Baseline, 1-week, and 3-months
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.
Measured: Baseline, 1-week, 1-month, and 3-months after psilocybin session
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.
Measured: Baseline, 1-week, 1-month, and 3-months after psilocybin session
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.
Measured: Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Dec 2023
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Woolley, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Woolley, MD, PhD, University of California, San Francisco
- Investigators
- Joshua Woolley, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351541
- Sponsor's protocol ID
- 20-21441
- Acronym
- POP
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05351541
- Acronym / sponsor ID
- POP / 20-21441
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic pain, Psilocybin, Psilocybin Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Joshua Woolley, MD, PhDUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin in combination with Zolpidem and Modafinil | Experimental | Drug: Psilocybin therapy with Zolpidem and ModafinilSingle dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil |
| Psilocybin in combination with Zolpidem | Experimental | Drug: Psilocybin therapy with ZolpidemSingle dose of Psilocybin (1mg-30mg) in combination with zolpidem |
| Psilocybin in combination with Modafinil | Experimental | Drug: Psilocybin therapy with ModafinilSingle dose of Psilocybin (1mg-30mg) in combination with modafinil |
| Psilocybin in combination with Placebo | Experimental | Drug: Psilocybin therapy with PlaceboSingle dose of Psilocybin (1mg-30mg) in combination with placebo |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin therapy with Zolpidem and ModafinilAlso: 4-phosphoryloxy- N,N-dimethyltryptamine1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration) | Drug | Psilocybin in combination with Zolpidem and Modafinil |
| Psilocybin therapy with ZolpidemAlso: 4-phosphoryloxy- N,N-dimethyltryptamine1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration) | Drug | Psilocybin in combination with Zolpidem |
| Psilocybin therapy with ModafinilAlso: 4-phosphoryloxy- N,N-dimethyltryptamine1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration) | Drug | Psilocybin in combination with Modafinil |
| Psilocybin therapy with PlaceboAlso: 4-phosphoryloxy- N,N-dimethyltryptamine1-30 mg (oral administration), and placebo (oral administration) | Drug | Psilocybin in combination with Placebo |
Primary outcome
Change in pain interference
Time frame: Baseline, 1-month after psilocybin session
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.
4 secondary outcomes
Change in pain interference
Time frame: Baseline, 1-week, and 3-months
Change in average pain intensity
Time frame: Baseline, 1-week, 1-month, and 3-months after psilocybin session
Change in clinical depressive symptom severity
Time frame: Baseline, 1-week, 1-month, and 3-months after psilocybin session
Change in depressive symptom severity
Time frame: Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Woolley principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psilocybin therapy with Zolpidem and Modafinil, Psilocybin therapy with Zolpidem and Psilocybin therapy with Modafinil in people with Chronic Low-back Pain, run by Joshua Woolley, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain interference (time frame: Baseline, 1-month after psilocybin session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.