The ME Association, a leading UK charity for people with ME/CFS (myalgic encephalomyelitis or encephalopathy; chronic fatigue syndrome) and Long Covid, has today announced investment in an important clinical trial in Canada to test the potential benefits of low-dose naltrexone (LDN). Results from the trial should help to clarify whether LDN can affect the underlying disease processes in ME/CFS and Long Covid and improve symptoms.
Dr Luis Nacul, principal investigator at the University of British Columbia (also at the London School of Hygiene & Tropical Medicine) is leading a double-blind, randomised, placebo-controlled trial with the B.C Women’s Health Research Institute in Canada.
The trial will determine if LDN improves fatigue, pain, sleep, orthostatic intolerance and other related symptoms, reduces inflammatory markers in blood, and enhances an individual’s quality of life. The trial will test LDN or a placebo in people who meet the American Institute of Medicine diagnostic criteria for ME/CFS at three months following a COVID-19 infection.
The impact of the COVID-19 pandemic makes finding evidence for an effective and safe treatment urgent. With currently no curative treatment for ME/CFS or Long Covid, a larger number of people are predicted to be impacted by the long-term morbidity and disability associated with these conditions, with high costs to healthcare and social services.
The ME Association’s latest investment reflects its increased commitment to biomedical research that could help deliver effective treatments for ME/CFS and Long Covid. Dr Charles Shepherd, honorary medical advisor and trustee at The ME Association explains, “Large numbers of people around the world are left disabled and often unable to work because of ME/CFS and Long Covid. While estimates vary, one thing is very clear, the urgent need for effective treatments.
“The ME Association is therefore very supportive of Dr Nacul’s clinical trial of a drug that has been long-considered a potential treatment of ME/CFS and more recently, Long Covid. A study of this nature is needed to determine if existing research relating to LDN’s use in Fibromyalgia and anecdotal evidence of its effective use in ME/CFS holds true under trial conditions.
“Only with trials such as this one will we be able to determine LDN’s actual effect. If we see improvements in people’s symptoms then we can lobby for the drug’s use in the UK. If the trial proves LDN has little or no effect, then we can move onto other potential treatments.”
Dr Luis Nacul, the trial’s principal investigator said, “We are excited by this study and delighted with the support from The ME Association. With the lack of specific treatments for Long-Covid and ME/CFS, there is a great need for trials such as this one. This is what those affected by these debilitating diseases expect from clinicians and researchers.”
The clinical trial will add to the growing experience and expertise of health professionals seeing cases of Long Covid and ME/CFS. Completion is expected by 31st December 2025, and results published in early 2026.