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Fibromyalgia and Naltrexone: The FINAL Study — FINAL  

Fibromyalgia Clinical Trial

Official title:
Fibromyalgia and Naltrexone: The FINAL Study

Clinical Trial Summary

This study evaluates the effect of low dose naltrexone (LDN) on pain in women with fibromyalgia (FM). The study is designed as a parallel randomized (1:1) double blind, placebo-controlled superiority trial. Half of the participants will receive treatment with LDN while the other half will receive treatment with placebo.

Clinical Trial Description

Low dose naltrexone (LDN) is used widely as off label treatment in patients with fibromyalgia, despite the lack of larger randomized controlled trials (RCT) supporting an effect. LDN has antagonistic effect on both opioid receptors and on toll-like receptors in glia cells. Mediated via those receptors, LDN can potentially reduce neuroinflammation and induce homeostasis in the endorphin system in patients with fibromyalgia. The aim of the trial is to investigate whether treatment with LDN has a superior effect compared to placebo on pain among female patients with fibromyalgia, evaluated after 12 weeks of treatment. The study is also exploring secondary aims regarding a possible improvement of other fibromyalgia core symptoms and a possible improvement of global assessment, daily functioning and health-related quality of life. Among the exploratory secondary objectives are changes in muscle exhaustion, physical fitness, pain sensitivity, inhibition of pain, augmentation of pain, and pro-inflammatory cytokines. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04270877
Study type Interventional
Source Odense University Hospital
Contact
Status Completed
Phase Phase 2
Start date January 6, 2021
Completion date December 27, 2022
View Details
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