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

NCT07285473 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB-3000159171UG3NS141843
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; ME/CFS

Outcome Measures

Primary Outcomes (1)

• PROMIS Fatigue Short Form 7a

  This will be measured using weekly surveys.

  10 months

Study Arms (1)

Participants Receiving Low-Dose Naltrexone

EXPERIMENTAL

Participants Receiving Low-Dose Naltrexone

Drug: Low-Dose Naltrexone, 1.5mg; Drug: Low-Dose Naltrexone, 3.0mg; Drug: Low-Dose Naltrexone, 4.5mg; Drug: Low-Dose Naltrexone, 6.0mg

Interventions

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.

Also known as: Naltrexone

Participants Receiving Low-Dose Naltrexone

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.

Also known as: Naltrexone

Participants Receiving Low-Dose Naltrexone

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.

Also known as: Naltrexone

Participants Receiving Low-Dose Naltrexone

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.

Also known as: Naltrexone

Participants Receiving Low-Dose Naltrexone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between ages of 18 and 65
• Living in Alabama
• Meets ME-ICC criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jarred Younger, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarred Younger, PhD

CONTACT

205-975-5821; youngerlab@uab.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This study is single-blind, participants will not know when they received 1.5mg/day, 3.0mg/day, 4.5mg/day, or 6.0mg/day low-dose naltrexone.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)