Not Yet RecruitingPhase 2

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

United States75 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between ages of 18 and 65 * Living in Alabama * Meets ME-ICC criteria Exclusion Criteria: * 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

What they're measuring

PROMIS Fatigue Short Form 7a

Timeframe: 10 months

Trial details

NCT IDNCT07285473

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-01

Contact for this trial

Jarred Younger, PhD

205-975-5821 youngerlab@uab.edu

View on ClinicalTrials.gov More Myalgic Encephalomyelitis/Chronic Fatigue Syndrome trials