This study is exploring different doses of Low-Dose Naltrexone (LDN) for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). LDN is a medication that will be specially prepared for this study, and you would take it by mouth once a day. Researchers want to see if LDN can help reduce fatigue, which will be measured over 10 months. To join, you must be between 18 and 65 years old, live in Alabama, and meet specific diagnostic criteria for ME/CFS. You cannot participate if you have certain health conditions, like abnormal liver or kidney function, or if you are pregnant. The study aims to enroll 75 participants, and its current recruitment status is unclear.

Study design

This is an interventional study where participants will receive one of four doses of Low-Dose Naltrexone (1.5mg, 3.0mg, 4.5mg, or 6.0mg) in a blinded way, meaning neither you nor the research staff will know which dose you are taking. It involves 75 participants.

What's involved

You would participate for 10 months, including a 30-day baseline period without medication, 8 months of taking daily LDN capsules, and a one-month endline phase without medication. You will complete weekly outcome measurements throughout the study.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint, PROMIS Fatigue Short Form 7a, is measured at 10 months, which is the total duration of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.