Low Dose Naltrexone for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long COVID Condition

Griffith University0 个研究点目标入组 56 人开始时间: 2024年9月24日最近更新: 2024年9月30日

适应症

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Griffith University
入组人数: 56
主要终点: 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]

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 65 Years（—）
性别: All

入选标准

•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.

排除标准

•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.

结局指标

主要结局

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]

次要结局

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]

研究者

发起方

Griffith University

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