Last updated: April 19, 2024
Sponsor: Fundació Sant Joan de Déu
Overall Status: Active - Not Recruiting
Phase
4
Condition
Fibromyalgia
Treatment
Low-dose naltrexone
Clinical Study ID
NCT04739995
ICI20/00080
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
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;
Exclusion
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) orinfection in the last 2 weeks; vaccination in the last 4 weeks; Take drugs withanti-inflammatory effects in the 72h prior to blood / neuroimaging; taking cortisone oranti-cytokine therapy; needle phobia; inability to be scanned (due to claustrophobia, metalimplants, pacemakers, etc.); Body Mass Index (BMI) > 36 kg/m2; consumption of > 8 units ofcaffeine per day; smoking > 10 cigarettes/day; acute pain not-related to FM on the day ofthe scan (e.g. headache, back pain).
Study Design
Total Participants: 99
Treatment Group(s): 1
Primary Treatment: Low-dose naltrexone
Phase: 4
Study Start date:
June 01, 2022
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Parc Sanitari Sant Joan de Déu (PSSJD)
Sant Boi De Llobregat, Barcelona 08830
SpainSite Not Available
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