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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07285473
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants Receiving Low-Dose Naltrexone
    Participants Receiving Low-Dose Naltrexone

Primary Outcome Measure

PROMIS Fatigue Short Form 7a [ Time Frame: 10 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35243
Catherine Burley
[email protected]
205-975-5907
Jarred Younger, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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