Clinical Trial: Immune Effects of Low-dose Naltrexone in ME/CFS

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)

Brief Summary: The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with CFS.

Detailed Summary:
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Reduction in plasma inflammatory biomarkers [ Time Frame: Four-week baseline; 12 weeks drug ]

Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Durability of reduction in plasma inflammatory biomarkers [ Time Frame: Baseline; 12 weeks drug; 24 weeks drug ]
    Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest. 24 weeks vs 12 weeks drug.
  • Reduction in self-reported fatigue [ Time Frame: 12 weeks drug ]
    Fatigue will be reported daily on a hand-held computer device.
  • Increase in physical function [ Time Frame: 12 weeks drug ]
    Physical function will be reported weekly on a Patient-Specific Functional Scale.
  • Reduction in self-reported symptoms of (i) depression, (ii) anxiety [ Time Frame: 12 weeks drug ]
    Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.


Original Secondary Outcome: Same as current

Information By: University of Alabama at Birmingham

Dates:
Date Received: November 14, 2016
Date Started: January 2016
Date Completion: August 2019
Last Updated: March 20, 2017
Last Verified: March 2017