RECRUITING

Cannabidiol for Reduction of Brain Neuroinflammation

Conditions

Back Pain Depressive Symptoms depression cannabis cannabidiol

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Cannabidiol for Reduction of Brain Neuroinflammation

Quick Facts

Study Start:2022-01-04

Study Completion:2026-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05066308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 and ≤ 75; 2. The ability to give written, informed consent; 3. Fluency in English; 4. 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; 5. On a stable pain treatment (pharmacological or otherwise) for the previous four weeks; 6. Diagnosis of chronic low back pain, ongoing for at least 6 months prior to enrollment. 7. High or mixed affinity binding to \[11C\]PBR28 identified by the Ala147Thr TSPO polymorphism in the TSPO gene (rs6971)	1. 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); 2. 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; 3. Any interventional pain procedures within 6 weeks prior to scanning procedure or at any point during study enrollment; 4. Surgical intervention or introduction/change in opioid regimen at any point during study enrollment; 5. 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); 6. Implanted spinal cord stimulator (SCS) for pain treatment; 7. Any history of neurological illness or major medical illness, unless clearly resolved without long-term consequences; 8. 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); 9. Harmful alcohol drinking as indicated by an AUDIT score ≥ 16; 10. Pregnancy or breast feeding; 11. History of head trauma requiring hospitalization; 12. Major cardiac event within the past 10 years; 13. Regular use of recreational drugs in the past 3 months; 14. 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; 15. Use of immunosuppressive medications, such as prednisone, TNF medications within 2 weeks of the visit; 16. Current bacterial or viral infection likely affecting the central nervous system; 17. Epilepsy; 18. Use of the medications valproate and clobazam, which may increase risk of hepatic AEs; 19. 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; 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).

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 and ≤ 75;
2. The ability to give written, informed consent;
3. Fluency in English;
4. 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;
5. On a stable pain treatment (pharmacological or otherwise) for the previous four weeks;
6. Diagnosis of chronic low back pain, ongoing for at least 6 months prior to enrollment.
7. High or mixed affinity binding to \[11C\]PBR28 identified by the Ala147Thr TSPO polymorphism in the TSPO gene (rs6971)

1. 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);
2. 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;
3. Any interventional pain procedures within 6 weeks prior to scanning procedure or at any point during study enrollment;
4. Surgical intervention or introduction/change in opioid regimen at any point during study enrollment;
5. 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);
6. Implanted spinal cord stimulator (SCS) for pain treatment;
7. Any history of neurological illness or major medical illness, unless clearly resolved without long-term consequences;
8. 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);
9. Harmful alcohol drinking as indicated by an AUDIT score ≥ 16;
10. Pregnancy or breast feeding;
11. History of head trauma requiring hospitalization;
12. Major cardiac event within the past 10 years;
13. Regular use of recreational drugs in the past 3 months;
14. 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;
15. Use of immunosuppressive medications, such as prednisone, TNF medications within 2 weeks of the visit;
16. Current bacterial or viral infection likely affecting the central nervous system;
17. Epilepsy;
18. Use of the medications valproate and clobazam, which may increase risk of hepatic AEs;
19. 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;
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).

Contacts and Locations

Study Contact

Jodi M Gilman, PhD

CONTACT

617-643-7293

jgilman1@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-04

Study Completion Date2026-12-15

Study Record Updates

Study Start Date2022-01-04

Study Completion Date2026-12-15

Terms related to this study

Keywords Provided by Researchers

back pain
depression
depressive symptoms
cannabis
cannabidiol

Additional Relevant MeSH Terms

Back Pain
Depressive Symptoms