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

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

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

Treatments tested in this trial

  • Low-Dose Naltrexone, 1.5mg
  • Low-Dose Naltrexone, 3.0mg
  • Low-Dose Naltrexone, 4.5mg
  • Low-Dose Naltrexone, 6.0mg

Treatment groups

75 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator