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

ConditionMyalgic Encephalomyelitis/Chronic Fatigue Syndrome

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between ages of 18 and 65

Living in Alabama

Meets ME-ICC criteria

Disqualifiers

Abnormal hepatic function

Abnormal renal function

Abnormal complete blood count

Evidence of active or chronic systemic infection

Trial design

Design model

Single group

Treatments tested in this trial

Low-Dose Naltrexone, 1.5mg
Drug
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.
Low-Dose Naltrexone, 3.0mg
Drug
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.
Low-Dose Naltrexone, 4.5mg
Drug
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.
Low-Dose Naltrexone, 6.0mg
Drug
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.

Treatment groups

75 Participants

are divided into 1 treatment group

Group A: Participants Receiving Low-Dose NaltrexoneExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

PROMIS Fatigue Short Form 7a

This will be measured using weekly surveys.

Time frame

10 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: