Low-Dose Naltrexone for Chronic Fatigue Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called low-dose naltrexone to determine its effectiveness for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a condition causing extreme tiredness and other symptoms. Researchers conduct the study remotely, allowing participants from across the U.S. to join. Ideal candidates have been diagnosed with ME/CFS, experience fatigue that significantly impacts daily life, and are not using opioid pain medication. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using opioid painkillers.
Is there any evidence suggesting that low-dose naltrexone is likely to be safe for humans?
Research has shown that low-dose naltrexone (LDN) is generally well-tolerated. In a study with patients experiencing ongoing fatigue after COVID-19, LDN proved to be safe. Another study found that 54.2% of patients reported feeling less fatigued after starting LDN. Additionally, a review of past patient records revealed that 53.8% of patients experienced relief from symptoms like pain and fatigue.
While these studies suggest LDN is safe for many people, no clinical trials specifically target LDN in patients with chronic fatigue syndrome or myalgic encephalomyelitis. Since this trial is in Phase 2, researchers are still gathering information on its safety and effectiveness for this condition.12345Why do researchers think this study treatment might be promising for chronic fatigue syndrome?
Low-Dose Naltrexone is unique because it offers a novel approach to managing Chronic Fatigue Syndrome (CFS) by modulating the immune system and reducing inflammation. Unlike traditional treatments that primarily focus on symptom relief, such as managing pain or sleep disturbances, Low-Dose Naltrexone works by targeting the body's opioid receptors to help regulate the immune response. Researchers are excited about this treatment because it has the potential to address the underlying causes of CFS, offering hope for more comprehensive symptom management and improved quality of life for patients.
What evidence suggests that low-dose naltrexone might be an effective treatment for chronic fatigue syndrome?
Research has shown that low-dose naltrexone (LDN) might benefit people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). In one study, 53.8% of patients reported improvement after using LDN, often experiencing reduced pain and fatigue. Another study found that LDN could aid those with persistent fatigue following COVID-19. This trial will assess the effects of LDN on participants with ME/CFS. Although research continues, these early findings offer promise for those considering LDN as a treatment option.1246
Who Is on the Research Team?
Jarred Younger, PhD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for individuals across the U.S. with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Specific eligibility criteria are not provided, but typically these would include age range, disease severity, and other health conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete weekly outcome measurements without taking any medications to establish a stable baseline
Treatment
Participants receive LDN capsules at one of four doses in a blinded fashion, with weekly adherence monitoring via REDCap surveys
Endline
Participants complete weekly outcome measurements without taking any medications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low-Dose Naltrexone
Trial Overview
The study explores different doses of Low-Dose Naltrexone (LDN) to treat ME/CFS. Participants will receive one of four possible doses: 1.5mg, 3.0mg, 4.5mg or 6.0mg to determine which works best.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants Receiving Low-Dose Naltrexone
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Citations
A Retrospective Cohort Study of One Pain Physician's Practice
Subjective symptom relief was reported by 53.8% of patients, most commonly improvements in pain (49 patients) and fatigue (25 patients), when ...
2.
ldnresearchtrust.org
ldnresearchtrust.org/ldn-research/low-dose-naltrexone-treatment-myalgic-encephalomyelitischronic-fatigue-syndrome-mecfsLow-dose naltrexone in the treatment of myalgic ...
Results: Outcome data were available in 92.2% of patients with an average follow-up time of 1.7 years. A positive treatment response to LDN was ...
Low-dose naltrexone and NAD+ for the treatment of ...
Our data suggest treatment with LDN and NAD+ is safe and may be beneficial in a subset of patients with persistent fatigue after COVID-19.
Low-Dose Naltrexone For ME/CFS: Dose-Finding
This exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) ...
Low-dose naltrexone as a treatment for chronic fatigue ...
We know of no clinical trials of naltrexone in patients with chronic fatigue syndrome or myalgic encephalomyelitis, although some patients report benefits.
Effect of low dose naltrexone for long covid: a systematic ...
In Tamariz 2024, 13 of 24 patients (54.2%) reported improved fatigue after starting LDN (21). Pain. Two studies reported pain outcomes, which ...
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