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Cannabidiol for Brain Neuroinflammation in Back Pain and Depression

This study is looking at whether Epidiolex (a cannabidiol, or CBD, medicine) can reduce brain inflammation in people with chronic low back pain, with or without mild-to-moderate depression. You might be able to join if you are 18-75 years old, speak English, and have had average worst daily pain of at least 4 out of 10 for at least half the days in a typical week. Participants will receive either Epidiolex or a placebo (an inactive substance that looks and tastes the same). The main goal is to see how much brain inflammation changes in a part of the brain called the thalamus after 4 weeks. The study is currently unclear on its recruitment status.

Study design
This is a randomized, double-blind study with two groups, meaning you'll be randomly assigned to receive either Epidiolex or a placebo, and neither you nor your doctors will know which you are receiving. It plans to enroll 80 participants.
What's involved
The study involves integrated PET/MRI scans to evaluate brain inflammation and function. The primary endpoint is measured at Week 4.
Compensation
Not stated in the trial record.
Follow-up
Changes are measured from the start of the study to Week 4.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05066308

Cannabidiol for Reduction of Brain Neuroinflammation

Recruiting
PHASE2Ages 18–75InterventionalBasic science
Massachusetts General Hospital
~80 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:CBDPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in Neuroinflammation in the Thalamus
Measured over Change from Baseline to Week 4

Conditions

Back Pain
Depressive Symptoms

Explore related trials

Chronic low back painDepressionTSPO Gene

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Jodi M Gilman, PhD
[email protected]
617-643-7293
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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).

What this trial measures

  • Changes in Neuroinflammation in the ThalamusChange from Baseline to Week 4

    The investigators will test for the presence of a significant treatment effect in the brain \[11C\]PBR28 signal in the thalamus, in order to test whether patients in the CBD arm will demonstrate significantly larger treatment-related reductions in neuroinflammation, compared to patients in the placebo arm.