Status:
WITHDRAWN
Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
VA Boston Healthcare System
Conditions:
Osteoarthritis
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Over 100 million Americans report chronic pain. One of the most common causes of chronic pain is osteoarthritis (OA). OA is attributable to "wear and tear," but reasons for pain are complex. Inflammat...
Detailed Description
Chronic pain affects over 100 million Americans, and arthritis is the most common cause. Existing treatments for chronic arthritic pain are only mildly effective, and risks of medications used to trea...
Eligibility Criteria
Inclusion
- One or more of the following chronic conditions: osteoarthritis, rheumatoid arthritis, or non-axial spondyloarthritis
- Average daily pain interference with function (average of the 7 parts of question 9 on the Brief Pain Inventory) rated at least 4 on a scale of 0-10, and no higher than 9
- No change in medication in the past 8 weeks made with the expectation of improving pain
- No plan to start another medication or a non-pharmacologic treatment regimen likely to affect pain during the next 16 weeks
- Age at least 18
- Capable of informed consent, and willingness to comply with study procedures, including receipt of weekly phone calls from the study coordinator
Exclusion
- Use of opioids including tramadol, in the past 7 days
- Pregnant, breast feeding, or unwilling to engage in contraceptive practices if sexually active and capable of conceiving
- Schizophrenia, bipolar disorder, or poorly controlled depression or anxiety
- Previous use of low-dose naltrexone for more than 8 weeks or in the past 2 weeks
- Back pain described by the patient as greater in severity than arthritic pain in all peripheral locations
- Significant kidney disease, defined as glomerular filtration rate \< 30 ml/min
- Liver cirrhosis. There is no specific screening procedure to exclude cirrhosis.
- Peripheral neuropathy described by the patient as greater in severity than arthritic pain. There is no specific screening procedure.
- Plan to have surgery during the next 16 weeks
- Other qualitative circumstances that the investigator feels would make the patient a poor candidate for this clinical trial, such as an unstable social situation or unreliable transportation
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04115020
Start Date
January 1 2020
End Date
January 7 2020
Last Update
January 9 2020
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115