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:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT04739995
Eligibility Criteria:
General Inclusion Criteria:
* Female between 18 and 70 years old
* Patients diagnosed of FM according to ACR 2016 criteria
* Chronic widespread pain for at least 6 months ranked ≥ 4 out of 10;
* Understand Spanish;
* Written informed written consent;
General Exclusion Criteria:
* Treatment with opiates in last 3 months;
* Diagnosis of severe medical/psychiatric disorders (e.g. cancer, severe depression, psychotic disorder, schizophrenia);
* Being pregnant (or planning a pregnancy during the study period) or breastfeeding;
* Known allergy to naltrexone or naloxone;
* Hematological disorders;
* Abnormal hepatic function;
* Taking anticoagulant medication;
* Alcohol consume during the study period
* Participation in other clinical trials;
Additional inclusion criteria for biomarker sub-study:
Right-handed (for the neuroimaging tests)
Additional exclusion criteria for biomarker sub-study:
Comorbid rheumatologic illnesses (e.g. rheumatoid arthritis, lupus); fever (\> 38ºC) or infection in the last 2 weeks; vaccination in the last 4 weeks; Take drugs with anti-inflammatory effects in the 72h prior to blood / neuroimaging; taking cortisone or anti-cytokine therapy; needle phobia; inability to be scanned (due to claustrophobia, metal implants, pacemakers, etc.); Body Mass Index (BMI) \> 36 kg/m2; consumption of \> 8 units of caffeine per day; smoking \> 10 cigarettes/day; acute pain not-related to FM on the day of the scan (e.g. headache, back pain).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04739995
Study Brief:
Protocol Section:
NCT04739995