A Phase 2 interventional study of Low-Dose Naltrexone, 1.5mg and Low-Dose Naltrexone, 3.0mg in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by University of Alabama at Birmingham · Phase 2, Interventional, and Treatment
This exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama.
This study uses a remote design where individuals can participate from anywhere in the state of Alabama. Study medications will be received by mail. All participants must meet ME-ICC criteria. This study will be tested on participants recruited from Alabama, with a total of 75 participants enrolled for the entire study. Participation will last 10 months.
The first stage of the study is the baseline phase. During this time, participants will complete weekly outcome measurements but will not take any medications. The baseline stage will last for 30 days. This period is used to calculate a stable baseline for determining treatment effects. After the 30-day baseline, the treatment stage will begin.
After the baseline period, participants will receive LDN capsules at one of four doses: 1.5mg/day, 3.0mg/day, 4.5mg/day, and/or 6.0mg/day in a blinded fashion. Capsules are sent by FedEx every two months and are taken daily without breaks. Participants and research assistants dealing with participants are blinded to the dose schedule. Data on adherence to the treatment protocol is monitored using smart pill dispensers. This treatment stage is the longest, lasting 8 months, with participants continuing to complete weekly outcome measures.
After eight months of study capsules, participants will enter a one-month endline phase where no medications are taken. Outcomes will still be completed once per week.
Exclusion Criteria:
Participants Receiving Low-Dose Naltrexone
Drug: Low-Dose Naltrexone, 1.5mg · Drug: Low-Dose Naltrexone, 3.0mg · Drug: Low-Dose Naltrexone, 4.5mg · Drug: Low-Dose Naltrexone, 6.0mg
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
Also known as: Naltrexone
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
Also known as: Naltrexone
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
Also known as: Naltrexone
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
Also known as: Naltrexone
PROMIS Fatigue Short Form 7a
This will be measured using weekly surveys.
Time frame: 10 months
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham