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

NCT07285473 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Interventions

DRUG

Low-Dose Naltrexone, 1.5mg

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.

DRUG

Low-Dose Naltrexone, 3.0mg

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.

DRUG

Low-Dose Naltrexone, 4.5mg

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.

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Jarred Younger, PhD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-04-01
Completion
2028-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07285473 on ClinicalTrials.gov