Cannabidiol for Reduction of Brain Neuroinflammation

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Back Pain, Depressive Symptoms

In brief

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.

Key facts

Study ID

NCT05066308

Run by

Massachusetts General Hospital

People needed

80

Starts

2022-01-04

Expected to finish

2026-12-15

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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);
• 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;
• Any interventional pain procedures within 6 weeks prior to scanning procedure or at any point during study enrollment;
• Surgical intervention or introduction/change in opioid regimen at any point during study enrollment;
• 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);
• Implanted spinal cord stimulator (SCS) for pain treatment;
• Any history of neurological illness or major medical illness, unless clearly resolved without long-term consequences;
• 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);
• Harmful alcohol drinking as indicated by an AUDIT score ≥ 16;
• Pregnancy or breast feeding;
• History of head trauma requiring hospitalization;
• Major cardiac event within the past 10 years;
• Regular use of recreational drugs in the past 3 months;
• 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;
• Use of immunosuppressive medications, such as prednisone, TNF medications within 2 weeks of the visit;
• Current bacterial or viral infection likely affecting the central nervous system;
• Epilepsy;
• Use of the medications valproate and clobazam, which may increase risk of hepatic AEs;
• 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;

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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