A double blind randomized trial of low-dose naltrexone for post-covid fatigue syndrome

Nacul, Luis | $742,331

British Columbia B.C. Women's Hospital 2021 CIHR Operating Grant

This study aims to determine whether low-dose naltrexone (LDN) improves energy and reduces fatigue and pain in people who had COVID‑19 (i.e. confirmed SARS-COV-2 positive) and have persistent symptoms of fatigue post-viral infection (PVI). Low-dose naltrexone (LDN) refers to naltrexone given in doses of 1-4.5 mg. Naltrexone is a medication that has been used in the treatment of excessive alcohol and opioids and for some types of itchiness. It has also been used, in low doses, for the relief of symptoms related to fibromyalgia (FM) and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The medication works differently when used in low doses compared to in high doses. Previous studies in people with FM found a significantly greater reduction in pain among those taking LDN compared to those taking placebo. Overall, the studies found that LDN is safe, well-tolerated, may reduce inflammation, and improves general health and psychological well-being. The proposed trial will be conducted at the Complex Chronic Diseases Program (CCDP), the provincial reference centre for treating ME/CFS and FM in British Columbia. The CCDP clinic has extensive experience in treating cases of FM and ME/CFS with LDN. We propose a placebo-controlled double-blind trial using LDN to treat patients with persistent symptoms of fatigue following SARS-COV-2 infection. We will find out whether people taking the medication show a reduction in symptom severity, such as sustained fatigue and pain, and improved quality of life. Individuals referred to as ‘Long-haulers’ or ‘Long-COVID’ currently do not have well researched drug interventions to treat their fatigue and related symptoms. The proposed study will demonstrate whether LDN is a medication that could benefit a large number of people with post-covid-19 fatigue illness. Furthermore, if this trial proves successful, it would lend support for further studies exploring LDN in other forms of post-viral fatigue, ME/CFS and FM populations.

With funding from the Government of Canada

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