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

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.

Participants will start at 1.5mg/day and will increase their dose by 1.5mg/day weekly until their maximum dose is reached (target 4.5-6mg/day) for 12 weeks. In this clinical trial, Naltrexone will be administered to all ME/CFS and long COVID 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 Oxford 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. Pharmacy will ensure records are kept of storage and dissemination of LDN. 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.