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New treatment option for Back Pain
Official title Cannabidiol for Reduction of Brain Neuroinflammation
ClinicalTrials.gov ID: NCT05066308
What this study is testing
What is CBD?
CBD is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for back pain.
Also referred to as Epidiolex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- On a stable pain treatment (pharmacological or otherwise) for the previous four weeks;
You likely can't join 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...
- Elevated baseline transaminase (ALT and AST) levels above 3 times the Upper Limit of Normal (ULN), accompanied by elevations in bilirubin above 2...
- Any treatment 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...
- Implanted spinal cord stimulator (SCS) for pain treatment;
See the full eligibility criteria
- 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)
- 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 treatment 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...
- 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...
- 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;
- 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...
- Use of opioids ≥ 30 mg morphine equivalents on average per month;
- 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;
- Allergy to sesame oil, and any other ingredients of EPIDIOLEX;
- Any other contraindications to CBD administration noted by the study physician;
- Any significant change in drug use and pain treatment from screening visit;
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.