Actively Recruiting
Cannabidiol for Reduction of Brain Neuroinflammation
Led by Massachusetts General Hospital · Updated on 2026-02-06
80
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will investigate whether cannabidiol (CBD), the primary centrally and peripherally active non-intoxicating compound in the cannabis plant, exerts anti-neuroinflammatory effects in patients with chronic low back pain (cLBP) with or without mild-to-moderate depression.
CONDITIONS
Official Title
Cannabidiol for Reduction of Brain Neuroinflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age ≥ 18 and ≤ 75;
- The ability to give written, informed consent;
- Fluency in English;
- 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;
- On a stable pain treatment (pharmacological or otherwise) for the previous four weeks;
- Diagnosis of chronic low back pain, ongoing for at least 6 months prior to enrollment.
- High or mixed affinity binding to [11C]PBR28 identified by the Ala147Thr TSPO polymorphism in the TSPO gene (rs6971)
You will not qualify if you...
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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);
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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;
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Any interventional pain procedures within 6 weeks prior to scanning procedure or at any point during study enrollment;
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Surgical intervention or introduction/change in opioid regimen at any point during study enrollment;
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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);
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Implanted spinal cord stimulator (SCS) for pain treatment;
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Any history of neurological illness or major medical illness, unless clearly resolved without long-term consequences;
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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);
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Harmful alcohol drinking as indicated by an AUDIT score ≥ 16;
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Pregnancy or breast feeding;
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History of head trauma requiring hospitalization;
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Major cardiac event within the past 10 years;
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Regular use of recreational drugs in the past 3 months;
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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;
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Use of immunosuppressive medications, such as prednisone, TNF medications within 2 weeks of the visit;
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Current bacterial or viral infection likely affecting the central nervous system;
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Epilepsy;
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Use of the medications valproate and clobazam, which may increase risk of hepatic AEs;
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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;
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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;
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Use of opioids ≥ 30 mg morphine equivalents on average per month;
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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;
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Allergy to sesame oil, and any other ingredients of EPIDIOLEX;
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Any other contraindications to CBD administration noted by the study physician;
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Any significant change in drug use and pain treatment from screening visit;
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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).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
J
Jodi M Gilman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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