low dose naltrexone in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and long coronavirus disease (long COVID) symptoms

Phase 1

Not yet recruiting

• Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS); Long COVID; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis); Infection - Other infectious diseases; Neurological - Other neurological disorders; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12624001162505
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-24
• Last Update Posted: 30 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

i.Aged between 18 and 65 years of ageii.BMI between 18.5 and 29.9iii.Diagnosed with ME/CFS by a physician at least 6 months ago.iv.Diagnosed with Long COVID according to WHO working case definition and present with the following symptoms: cognitive disturbances otherwise known as brain fog, sleep disturbances, and/or body pain. This clinical trial will not assess symptoms including gastrointestinal upset, autonomic or orthostatic intolerances, and respiratory difficulties.

Exclusion Criteria

i.Current respiratory infectionsii.Intercurrent SARS-CoV-2 reinfection during trial period (this will be considered drop-out)iii.Chronic pain historyiv.Adverse reaction to LDN or compounded constituentsv.Chronic opioid or substitution therapyvi.Daily opioid use in three months prior to, or during trialvii.Substance abuse, dependence, addictionviii.History of drug, alcohol abuse and recreational drugsix.Smoking within last 2 yearsx.Pregnancy or breastfeedingxi.Renal dysfunction (eGFR less than or equal to 30 ml/min/1.73m2), liver dysfunction (ALT or AST greater than 300 IU/L).xii.Active cancer.xiii.Inflammatory (rheumatological, GIT, dermatological) or neurological condition (demyelinating).xiv.Neuroimmune modulators: DMARDs, steroids, minocycline, metformin.xv.Major psychiatric history, self-harm.xvi.Language, cognition, no computer literacy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Transient receptor potential cation channel subfamily M member 3 (TRPM3) function[Assessed using the gold standard patch-clamp technique 12 weeks after intervention commencement. ];Assess brain function by examining functional connectivity, changes in brain neurochemicals, myelin, iron and brain structure. This will be assessed as a composite outcome[Assessed by Magnetic Resonance Imaging (MRI) 12 weeks after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
General quality of life[SF-36 questionnaire 12 weeks after intervention commencement. ];Disability assessment [WHODAS questionnaire 12 weeks after intervention commencement];ME/CFS symptoms assessment [Depaul questionnaire 12 weeks after intervention commencement]