A Phase 1/2 interventional study of Psilocybin therapy with Zolpidem and Modafinil and Psilocybin therapy with Zolpidem in Chronic Low-back Pain, sponsored by Joshua Woolley, MD, PhD. Completed at 1 site in United States. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Joshua Woolley, MD, PhD · Phase 1/2, Interventional, and Treatment
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.
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Joshua Woolley, MD, PhD is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil
Drug: Psilocybin therapy with Zolpidem and Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem
Drug: Psilocybin therapy with Zolpidem
Single dose of Psilocybin (1mg-30mg) in combination with modafinil
Drug: Psilocybin therapy with Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with placebo
Drug: Psilocybin therapy with Placebo
1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine
1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine
1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine
1-30 mg (oral administration), and placebo (oral administration)
Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine
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.
Time frame: Baseline, 1-month after psilocybin session
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in Aug 2026, 32 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Jul 2026 → Aug 2026 and completion Sep 2026 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Joshua Woolley, MD, PhD