Last updated: April 12, 2022
Sponsor: Massachusetts General Hospital
Overall Status: Terminated
Phase
4
Condition
Chronic Pain
Treatment
N/AClinical Study ID
NCT03891264
2019P000852
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- age ≥ 18 and ≤ 75;
- the ability to give written, informed consent;
- ongoing pain that averaged at least 4, on a 0-10 scale of pain during a typical week,and present for at least 50% of days during a typical week;
- fluency in English;
- on a stable pain treatment (pharmacological or otherwise) for the previous four weeks.
- Medical records confirming diagnosis of low back pain
- Chronic low back pain, ongoing for at least 6 months prior to enrollment.
Exclusion
Exclusion Criteria:
- outpatient surgery within 2 months and inpatient surgery within 6 months from the timeof scanning;
- elevated baseline transaminase (ALT and AST) levels above 3 times the Upper Limit ofNormal (ULN), accompanied by elevations in bilirubin above 2 times the ULN
- any interventional pain procedures within 6 weeks prior to scanning procedure or atany point during study enrollment;
- surgical intervention or introduction/change in opioid regimen at any point duringstudy enrollment
- contraindications to functional magnetic resonance imaging scanning and positronemission tomography scanning (including presence of a cardiac pacemaker or pacemakerwires, metallic particles in the body, vascular clips in the head or previousneurosurgery, prosthetic heart valves, claustrophobia);
- current or past history within the last 5 years of major medical illness not affectingthe central nervous system, other than chronic pain;
- implanted spinal cord stimulator (SCS) for pain treatment;
- any history of neurological illness or major medical illness affecting the centralnervous system, 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 sosevere as to require hospitalization in the past year.
- pregnancy or breast feeding;
- history of head trauma requiring hospitalization;
- major cardiac event within the past 10 years;
- any use of recreational drugs in the past 3 months
- any marijuana use, medical or recreational, in the past 3 months
- an abnormal physical exam (e.g., peripheral edema);
- routine use of opioids ≥ 60 mg morphine equivalents;
- use of immunosuppressive medications, such as prednisone, TNF medications within 2weeks of the visit;
- current bacterial or viral infection;
- Any other contraindications to CBD administration noted by the study physician.
- If undergoing blood draws through an arterial line during scan, contraindications toplacement of arterial line, such as abnormal result on modified Allen's test on bothhands; Raynaud syndrome; bleeding disorder; use of anticoagulants such as Coumadin,Plavix or Lovenox
Study Design
Total Participants: 7
Study Start date:
November 13, 2019
Estimated Completion Date:
November 23, 2020
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available

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