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NOT YET RECRUITING
NCT07285473
PHASE2

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Official title: Low-dose Naltrexone (LDN) for the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Dose-Finding

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-07-01

Completion Date

2028-04-01

Last Updated

2026-04-06

Healthy Volunteers

No

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States