Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT04115020
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04115020
Study Brief:
Protocol Section:
NCT04115020