Status:
ACTIVE_NOT_RECRUITING
Cost-utility and Physiological Effects of LDN in Patients With Fibromyalgia
Lead Sponsor:
Fundació Sant Joan de Déu
Collaborating Sponsors:
Carlos III Health Institute
Conditions:
Randomized Controlled Trial
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
Background: Low-dose naltrexone (LDN) may be useful in managing the pathologies that alter inflammatory markers, such as Crohn's disease or fibromyalgia (FM). The anti-inflammatory effect of LDN shoul...
Detailed Description
Low-dose Naltrexone (LDN): A potential treatment for fibromyalgia (FM) Naltrexone is an opioid antagonist used for treating opiate and alcohol dependency that blocks the mu receptors and, to a lesser...
Eligibility Criteria
Inclusion
- General
- 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
- 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).
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04739995
Start Date
June 1 2022
End Date
December 31 2024
Last Update
April 22 2024
Active Locations (1)
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1
Parc Sanitari Sant Joan de Déu (PSSJD)
Sant Boi de Llobregat, Barcelona, Spain, 08830