Can Low-Dose Naltrexone Reduce the Symptoms of ME/CFS?
Unlike fibromyalgia, there are no FDA-approved treatments for ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome), leaving few options for relieving symptoms.
But in recent years, a growing number of patients have started using a little-known drug called low-dose naltrexone (LDN) as an off-label treatment. In 2016, an Alabama-based researcher was planning the first trial to find out if LDN actually reduced ME/CFS symptoms. To the dismay of the ME/CFS community, the trial was suspended — neither the participants nor the protocol ever began. There is no further information regarding when or if this clinical trial will ever take place.
Benefits of LDN
While the research for LDN and ME/CFS is on pause indefinitely, the FDA has previously approved naltrexone for some health conditions: Originally, it was used to treat addiction to certain opiate drugs in 1984. But in low doses (typically 1-4.5 mg), naltrexone enhances the body’s immune system by boosting the production of endorphins, which in turn promotes healing and lessens inflammation. So far, the benefits of LDN have been found useful in the treatment of certain autoimmune and central nervous system conditions, including multiple sclerosis, Crohn’s disease, rheumatoid arthritis, and others.
While at Stanford University, Jarred Younger, PhD conducted research to find out if LDN might relieve fibromyalgia pain. The results showed LDN was actually more effective than the three drugs currently approved by the FDA to treat fibromyalgia.
In 2014, Younger moved his research to the University of Alabama at Birmingham and opened the Neuroinflammation, Pain and Fatigue Laboratory. He decided to test LDN in ME/CFS after reading testimonials on PatientsLikeMe and similar websites from patients who said their fatigue and pain lifted after using LDN.
Can LDN reduce the symptoms of ME/CFS? A number of researchers, including Younger, believe fibromyalgia and ME/CFS may be related conditions. Younger speculates if LDN works well in fibromyalgia patients, then it might also work as an ME/CFS treatment. In 2017, he began recruiting patients to test his theory.
ME/CFS patients have very few options to deal with the debilitating fatigue that’s the hallmark of their condition. Some physicians prescribe amphetamines, like Ritalin or Adderall, but this class of drugs can cause insomnia, rapid heartbeat, psychosis and other harmful side effects. These drugs also can become less effective over time.
Younger believes the symptoms of ME/CFS and fibromyalgia may be caused by brain inflammation. The brain contains microglial cells, which are constantly scanning and looking for problems within the central nervous system. When they discover a problem, these cells release chemicals, which cause fatigue, pain, cognitive disturbances, and other symptoms commonly associated with ME/CFS and fibromyalgia. In a healthy person, these chemicals are supposed to slow down the body, so the immune system can focus on healing. But in ME/CFS and fibromyalgia, some researchers think this normal bodily response gets activated and won’t shut off.
Subscribe to the World's Most Popular Newsletter (it's free!)
The Hurdles of an ME/CFS Clinical Trial
The reason LDN may work in fibromyalgia and hold promise for those with ME/CFS is because it calms the microglial cells and reduces brain inflammation. In 2016, Younger began trying to raise around $4 million to fund a fast-track clinical trial center, which would enable his team to test out multiple treatments for ME/CFS and fibromyalgia simultaneously. It would rely on the support of donors, cutting through the federal government’s long waits for funding.
On average, it takes about eight to ten years for a treatment to navigate through the federal government’s grant system before it’s ready for public use. Younger’s center was hoping to cut that time to about three years. As of 2019, the clinical trial appears to be ongoing and no further studies have been published. Meanwhile, we have groundbreaking diagnostic blood tests for ME/CFS on the horizon.
This article was first published on ProHealth.com on May 16, 2016 and was updated on August 29, 2019.
Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She covers news, treatments, research and tips for living better with fibromyalgia on her blog, FedUpwithFatigue.com, which includes a helpful resources page on using low-dose naltrexone for fibromyalgia and ME/CFS. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.
1. Immune Effects of Low-dose Naltrexone in ME/CFS. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02965768
2. Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis and Rheumatism. 2013 Feb; 65(2): 529-38. doi: 10.1002/art.37734