Low-Dose Naltrexone For ME/CFS: Dose-Finding

Starting soon · Phase 2

Conditions studied: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

In brief

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.

Key facts

Study ID

NCT07285473

Run by

University of Alabama at Birmingham

People needed

75

Starts

2026-09-01

Expected to finish

2028-04-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between ages of 18 and 65
• Living in Alabama
• Meets ME-ICC criteria

You may not qualify if…

• Abnormal hepatic function
• Abnormal renal function
• Abnormal complete blood count
• Evidence of active or chronic systemic infection
• A1C > 9.0%
• Current opioid analgesic use
• Pregnant or plans to become pregnant during the study participation period
• Auto-immune disorder
• Enrolled in other experimental treatment study

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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