low dose naltrexone in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and long coronavirus disease (long COVID) symptoms
Low Dose Naltrexone for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long COVID Condition
Griffith University
56 participants
Oct 15, 2024
Interventional
Conditions
Summary
There is no laboratory-based diagnostic test and universally accepted treatment for ME/CFS and Long COVID, instead diagnosis follows fulfilment of a diagnostic criteria. The study aims to determine if treatment with Low Dose Naltrexone (LDN) improves ion channels function, fatigue, cognitive, neurological symptoms, and health-related quality-of-life (HRQoL) in adults with ME/CFS and Long COVID. If this is the case, Low Dose Naltrexone (LDN) may offer a safe and cost-effective treatment for ME/CFS and Long COVID. The investigational production Low Dose Naltrexone (LDN) will be manufactured, packaged, labelled, coded, stored, supplied, and handled in accordance with the requirements of sections 5.13 and 5.14 of the Therapeutic Goods Administration’s Integrated Addendum. Specifically, Low Dose Naltrexone (LDN) will be manufactured in accordance with good manufacturing practices (GMP) and will be coded or labelled by the compounding pharmacy. While Low Dose Naltrexone (LDN) and placebo will be blinded, a coding system will be implemented to enable rapid identification of the product for safety reasons. Specifically, Low Dose Naltrexone (LDN) capsules are to be stored at room temperature in their original container for up to six months. Low Dose Naltrexone (LDN) will be labelled with a specific expiration date by the compounding pharmacy.
Eligibility
Inclusion Criteria4
- i. Aged between 18 and 65 years of age
- ii. BMI between 18.5 and 29.9
- iii. 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 Criteria16
- i. Current respiratory infections
- ii. Intercurrent SARS-CoV-2 reinfection during trial period (this will be considered drop-out)
- iii. Chronic pain history
- iv. Adverse reaction to LDN or compounded constituents
- v. Chronic opioid or substitution therapy
- vi. Daily opioid use in three months prior to, or during trial
- vii. Substance abuse, dependence, addiction
- viii. History of drug, alcohol abuse and recreational drugs
- ix. Smoking within last 2 years
- x. Pregnancy or breastfeeding
- xi. 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.
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Interventions
Participants will start at 1.5mg/day and will increase their dose by 1.5mg/day weekly until their maximum dose is reached (target 4-6mg/day) for 12 weeks. In this clinical trial, Naltrexone will be administered to all ME/CFS and long COVID-19 who meet the recruitment criteria from the clinicians. Low dose naltrexone will be administered in oral capsules. Placebo participants will receive an exact replica capsule. LDN and placebo capsule will be distributed to participants via post. The study treatment will be received by the Wesley Hospital Pharmacy designated staff, handled, and stored safely within a secure location to which only pharmacy staff have access. Upon receipt, all investigational products will be stored according to the instructions specified on the labels. The investigators will maintain an accurate record of the shipment and dispensing of study treatment in a drug accountability log. Monitoring of drug accountability will be performed by the study investigators. Participants will keep a drug diary for daily completion for investigators to monitor. Participants will be asked to return all unused study treatments and package at the end of either a dose escalation, end of the study trial, or discontinuation of the treatment. Returned investigational products will be assessed for compliancy. Compliance will be assessed by the investigators at the end of each month using pill return counts and information provided by the patient. This information should be captured in the source documents at each visit. All study treatment dispensed and returned must be recorded in the drug accountability log. The site will also be required to complete the appropriate dosage administration record to report any study drug regimen changes or interruptions. For all medications (other than study regimen) initiated after the start of the study, the reasons for prescribing the medication, the start date, and, where applicable, the end dates will be recorded in the participant’s file. Information regarding the administration of rescue medication will be recorded in the participant’s file. Participants will receive instructions to notify investigators of any new medications they take after the participant has enrolled in the study. All medications, procedures, and significant non-drug therapies (e.g., physical therapy and blood transfusions) administered after the patient has enrolled will be recorded.
Locations(1)
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ACTRN12624001162505