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Can CBD cool brain inflammation and ease back pain and depression?

NCT ID NCT05066308

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether cannabidiol (CBD), a non-intoxicating compound from cannabis, can reduce inflammation in the brain. Researchers will give CBD or a placebo to 80 adults with chronic low back pain, with or without mild-to-moderate depression. They will use brain scans to measure changes in inflammation and see if symptoms improve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cannabidiol (CBD) oral solution
What this could lead to
If it works, this could point toward a new way to treat chronic back pain and depression by reducing brain inflammation.
What could go wrong
This is a small, early-stage trial. CBD may not reduce inflammation or improve symptoms, and results may not apply to everyone with back pain or depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 and ≤ 75; 2. The ability to give written, informed consent; 3. Fluency in English; 4. Average worst daily pain of at least 4 on a 0-10 scale of pain intensity, during a typical day. Pain needs to be present for at least 50% of days during a typical week; 5. On a stable pain treatment (pharmacological or otherwise) for the previous four weeks; 6. Diagnosis of chronic low back pain, ongoing for at least 6 months prior to enrollment. 7. High or mixed affinity binding to \[11C\]PBR28 identified by the Ala147Thr TSPO polymorphism in the TSPO gene (rs6971) Exclusion Criteria: 1. Outpatient surgery within 2 weeks and inpatient surgery within 1 month of the time of scanning (this timeframe may be extended if they are not fully recovered from the surgery); 2. Elevated baseline transaminase (ALT and AST) levels above 3 times the Upper Limit of Normal (ULN), accompanied by elevations in bilirubin above 2 times the ULN; 3. Any interventional pain procedures within 6 weeks prior to scanning procedure or at any point during study enrollment; 4. Surgical intervention or introduction/change in opioid regimen at any point during study enrollment; 5. Contraindications to fMRI scanning and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia); 6. Implanted spinal cord stimulator (SCS) for pain treatment; 7. Any history of neurological illness or major medical illness, unless clearly resolved without long-term consequences; 8. Current or past history of major psychiatric illness (PTSD, depression, and anxiety are exclusion criteria only if the conditions were so severe as to require hospitalization in the past year); 9. Harmful alcohol drinking as indicated by an AUDIT score ≥ 16; 10. Pregnancy or breast feeding; 11. History of head trauma requiring hospitalization; 12. Major cardiac event within the past 10 years; 13. Regular use of recreational drugs in the past 3 months; 14. Use of cannabis-containing products, such as products containing THC or over the-counter or dispensary CBD, for 2 weeks prior to starting the study medication and during the 4 weeks of taking the study medication; 15. Use of immunosuppressive medications, such as prednisone, TNF medications within 2 weeks of the visit; 16. Current bacterial or viral infection likely affecting the central nervous system; 17. Epilepsy; 18. Use of the medications valproate and clobazam, which may increase risk of hepatic AEs; 19. Safety concerns related to use of any of the following medications will be discussed on an individualized basis with a physician: * Strong and moderate CYP3A4 inhibitors including boceprevir, cobicistat, conivaptan, danoprevir, elvitegravir, ritonavir, indinavir, itraconazole, ketoconazole, lopinavir, paritaprevir and ombitasvir and/or dasabuvir, posaconazole, saquinavir and telaprevir, tipranavir, clarithromycin, diltiazem, idelalisib, nefazodone, nelfinavir, troleandomycin, voriconazole, aprepitant, cimetidine, ciprofloxacin, clotrimazole, crizotinib, cyclosporine, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, tofisopam, disulfiram, and verapamil; * Strong and moderate inhibitors of CYP2C19 including fluoxetine and ticlopidine; * Sensitive and moderately sensitive substrates of CYP2C19 including clobazam, lansoprazole, omeprazole, S-mephenytoin, and rabeprazole; * Sensitive and moderately sensitive substrates of CYP1A2 including alosetron, duloxetine, ramelteon, tasimelteon, theophylline, tizanidine, pirfenidone, and ramosetron; * Sensitive and moderately sensitive substrates of CYP2B6 including bupropion and efavirenz; * Sensitive and moderately sensitive substrates of CYP2C8 including repaglinide, montelukast, pioglitazone, and rosiglitazone; * Sensitive and moderately sensitive substrates of CYP2C9 including tolbutamide, celecoxib, glimepiride, and warfarin; * Sensitive and moderately sensitive substrates of UGT1A9 including diflunisal, propofol, and fenofibrate; * Sensitive and moderately sensitive substrates of UGT2B7 including, gemfibrozil, lamotrigine, and morphine; 20. CNS depressants including all antipsychotics, benzodiazepines (except for alprazolam, clonazepam, and lorazepam, which have low binding affinity to TSPO44-48), and non-benzodiazepine sleep aids that have a known unsafe reaction with CBD; 21. Use of opioids ≥ 30 mg morphine equivalents on average per month; 22. Actively suicidal, history of suicide attempt or an aborted attempt within the last 5 years, or engagement in non-suicidal self-injurious behavior within the last year; 23. Allergy to sesame oil, and any other ingredients of EPIDIOLEX; 24. Any other contraindications to CBD administration noted by the study physician; 25. Any significant change in drug use and pain treatment from screening visit; 26. In the opinion of the investigators, unable to safely participate in this study and/or provide reliable data (e.g., unable to reliably rate pain; unlikely to remain still during the imaging procedures, etc).

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Conditions

The condition(s) this trial relates to.

Back Pain cannabis dependence Depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.