Back PainPhase 2CBDNCT05066308
Cannabidiol for Reduction of Brain Neuroinflammation
A Phase 2 study testing CBD in people with Back Pain and Depressive Symptoms, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Back Pain, Depressive Symptoms
- What is being tested?
- CBD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 1 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 35Show fewer
- 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;
- 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 reaction with CBD;
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of Cannabidiol for Reduction of Brain Neuroinflammation
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.
Read the detailed description
This is a randomized, double-blind, 2-arm mechanistic trial that seeks to assess the effects of CBD and placebo in patients with cLBP with and without mild-to-moderate depression, using integrated positron emission tomography / magnetic resonance imaging (PET/MRI) scans. The use of integrated PET/MRI will make it possible to simultaneously evaluate neuroinflammation (using [11C]PBR28, a second-generation radioligand for TSPO) and striatal function (using the Monetary Incentive Delay task, a validated fMRI task that probes behavioral and neural responses to rewards and losses).
- Conditions
- Back Pain, Depressive Symptoms
- Being tested
- CBD, Placebo
- Keywords
- back pain, depression, depressive symptoms, cannabis, cannabidiol
- Medical subject headings
- Back Pain, Depression, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
Also called Epidiolex
Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. The drug is formulated from extracts prepared from Cannabis sativa L. plants that have a defined chemical profile and contain consistent levels of CBD as the principal phytocannabinoid. Extracts from these plants are processed to yield pure (>95%) CBD that typically contains less than 0.5% (w/w) THC. Cannabidiol is the active ingredient in Epidiolex; inactive ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose. Of note, CBD has no psychoactive properties.
PlaceboOther
Placebo CBD will be identical to the active CBD, a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring, but with no CBD.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | The recommended starting dosage is 2.5mg/kg taken twice daily. The titration schedule recommended in the EPIDIOLEX label will be followed, with 2.5 mg/kg twice daily in week 1, 5 mg/kg twice daily in week 2, 7.5 mg/kg twice daily in week 3, and 10 mg/kg twice daily in week 4 with the second PET scan conducted after one week at the maximum labeled dose. Any participant not tolerating a given dose can either go back down to the next lowest dose or delay uptitration at any week in the protocol. Participants will be instructed to take Epidiolex with a meal rather than in a fasted state. Participants will be treated for 4 weeks in total. Receives: Drug: CBD |
| Placebo | Placebo comparator | The placebo will be taken at identical doses to the active drug condition. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Neuroinflammation in the Thalamus
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.
Measured: Change from Baseline to Week 4
Secondary outcomes (7)
Changes in Neuroinflammation in Limbic Regions
The investigators will test for the presence of a significant treatment effect in the brain [11C]PBR28 in limbic regions (pgACC, aMCC), 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.
Measured: Change from Baseline to Week 4
Correlation Between Reductions in Thalamic [11C]PBR28 PET Signal and Reductions in Clinical Pain Ratings
The investigators will test whether reductions in thalamic [11C]PBR28 PET signal correlate with reductions in clinical pain ratings, as assessed by the "worst pain" item of the Brief Pain Inventory - Short Form. The "worst pain" item's scale ranges from 0 - 10, with a higher score indicating worse pain intensity.
Measured: Change from Baseline to Week 4
Correlation Between Reductions in Limbic [11C]PBR28 PET Signal and Reductions in Depressive Symptoms
The investigators will test whether reductions in pgACC/aMCC [11C]PBR28 PET signal (as measured by Standardized Uptake Value Ratio) correlate with reductions in depressive symptoms, as measured by the Beck Depression Inventory-II. The Beck Depression Inventory-II scale ranges from 0 - 63, with a higher score indicating greater depression.
Measured: Change from Baseline to Week 4
Change in Clinical Pain Ratings
The "worst pain" item of the Brief Pain Inventory - Short Form will be used daily to assess pain intensity. The scale ranges from 0 - 10, with a higher score indicating worse pain intensity.
Measured: Change from average score during the 7 days prior to treatment (Baseline) to average score during the final week of treatment
Change in Pain Bothersomeness
Pain bothersomeness will be assessed daily on a scale from 0 - 10, with a higher score indicating greater bothersomeness.
Measured: Change from average score during the 7 days prior to treatment (Baseline) to average score during the final week of treatment
Change in Depressive Symptoms
The Beck Depression Inventory-II will be used to assess symptoms of depression. The scale ranges from 0 - 63, with a higher score indicating greater depression.
Measured: Change from Baseline to Week 4
Patient Global Impression of Change
The Patient Global Impression of Change scale will be used to assess participants' perceptions about their global improvement related to their low back pain. The scale ranges from 0 - 7, with a higher score indicating greater overall improvement.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start4 Jan 2022
- Primary completion17 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jodi Gilman, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066308
- Sponsor's protocol ID
- 2021P002617
- Acronym
- CBD
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data, code, and materials used in the analyses can be provided by Jodi Gilman and Marco Loggia and Massachusetts General Hospital pending scientific review and a completed data use agreement/material transfer agreement beginning one year after publication of the results. Requests for all materials should be submitted to Jodi Gilman at jgilman1@mgh.harvard.edu or to Marco Loggia at marco.loggia@mgh.harvard.edu.
Publications
Pike CK, Kim M, Schnitzer K, Mercaldo N, Edwards R, Napadow V, Zhang Y, Morrissey EJ, Alshelh Z, Evins AE, Loggia ML, Gilman JM. Study protocol for a phase II, double-blind, randomised controlled trial of cannabidiol (CBD) compared with placebo for reduction of brain neuroinflammation in adults with chronic low back pain. BMJ Open. 2022 Sep 19;12(9):e063613. doi: 10.1136/bmjopen-2022-063613.
PubMed 36123113
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cannabidiol for Reduction of Brain Neuroinflammation
- ClinicalTrials.gov ID
- NCT05066308
- Acronym / sponsor ID
- CBD / 2021P002617
- Conditions
- Back Pain, Depressive Symptoms
- Keywords
- back pain, depression, depressive symptoms, cannabis, cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, 2-arm mechanistic trial that seeks to assess the effects of CBD and placebo in patients with cLBP with and without mild-to-moderate depression, using integrated positron emission tomography / magnetic resonance imaging (PET/MRI) scans. The use of integrated PET/MRI will make it possible to simultaneously evaluate neuroinflammation (using [11C]PBR28, a second-generation radioligand for TSPO) and striatal function (using the Monetary Incentive Delay task, a validated fMRI task that probes behavioral and neural responses to rewards and losses).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: CBDThe recommended starting dosage is 2.5mg/kg taken twice daily. The titration schedule recommended in the EPIDIOLEX label will be followed, with 2.5 mg/kg twice daily in week 1, 5 mg/kg twice daily in week 2, 7.5 mg/kg twice daily in week 3, and 10 mg/kg twice daily in week 4 with the second PET scan conducted after one week at the maximum labeled dose. Any participant not tolerating a given dose can either go back down to the next lowest dose or delay uptitration at any week in the protocol. Participants will be instructed to take Epidiolex with a meal rather than in a fasted state. Participants will be treated for 4 weeks in total. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo will be taken at identical doses to the active drug condition. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (35 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBDAlso: EpidiolexEpidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. The drug is formulated from extracts prepared from Cannabis sativa L. plants that have a defined chemical profile and contain consistent levels of CBD as the principal phytocannabinoid. Extracts from these plants are processed to yield pure (>95%) CBD that typically contains less than 0.5% (w/w) THC. Cannabidiol is the active ingredient in Epidiolex; inactive ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose. Of note, CBD has no psychoactive properties. | Drug | Cannabidiol (CBD) |
| PlaceboPlacebo CBD will be identical to the active CBD, a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring, but with no CBD. | Other | Placebo |
Primary outcome
Changes in Neuroinflammation in the Thalamus
Time frame: Change 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.
7 secondary outcomes
Changes in Neuroinflammation in Limbic Regions
Time frame: Change from Baseline to Week 4
Correlation Between Reductions in Thalamic [11C]PBR28 PET Signal and Reductions in Clinical Pain Ratings
Time frame: Change from Baseline to Week 4
Correlation Between Reductions in Limbic [11C]PBR28 PET Signal and Reductions in Depressive Symptoms
Time frame: Change from Baseline to Week 4
Change in Clinical Pain Ratings
Time frame: Change from average score during the 7 days prior to treatment (Baseline) to average score during the final week of treatment
Change in Pain Bothersomeness
Time frame: Change from average score during the 7 days prior to treatment (Baseline) to average score during the final week of treatment
Change in Depressive Symptoms
Time frame: Change from Baseline to Week 4
Patient Global Impression of Change
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 36123113Pike CK, Kim M, Schnitzer K, Mercaldo N, Edwards R, Napadow V, Zhang Y, Morrissey EJ, Alshelh Z, Evins AE, Loggia ML, Gilman JM. Study protocol for a phase II, double-blind, randomised controlled trial of cannabidiol (CBD) compared with placebo for reduction of brain neuroinflammation in adults with chronic low back pain. BMJ Open. 2022 Sep 19;12(9):e063613. doi: 10.1136/bmjopen-2022-063613.
- Individual participant dataSharing planned: Yes. All data, code, and materials used in the analyses can be provided by Jodi Gilman and Marco Loggia and Massachusetts General Hospital pending scientific review and a completed data use agreement/material transfer agreement beginning one year after publication of the results. Requests for all materials should be submitted to Jodi Gilman at jgilman1@mgh.harvard.edu or to Marco Loggia at marco.loggia@mgh.harvard.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBD in people with Back Pain and Depressive Symptoms, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Neuroinflammation in the Thalamus (time frame: Change from Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05066308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.