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Not yet recruiting NCT07285473

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

Phase II Interventional Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-Dose Naltrexone, 1.5mg, Low-Dose Naltrexone, 3.0mg, Low-Dose Naltrexone, 4.5mg, Low-Dose Naltrexone, 6.0mg.
Who it may be relevant to
Registry conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

This study uses a remote design where individuals can participate from anywhere in the state of Alabama. Study medications will be received by mail. All participants must meet ME-ICC criteria. This study will be tested on participants recruited from Alabama, with a total of 75 participants enrolled for the entire study. Participation will last 10 months.

The first stage of the study is the baseline phase. During this time, participants will complete weekly outcome measurements but will not take any medications. The baseline stage will last for 30 days. This period is used to calculate a stable baseline for determining treatment effects. After the 30-day baseline, the treatment stage will begin.

After the baseline period, participants will receive LDN capsules at one of four doses: 1.5mg/day, 3.0mg/day, 4.5mg/day, and/or 6.0mg/day in a blinded fashion. Capsules are sent by FedEx every two months and are taken daily without breaks. Participants and research assistants dealing with participants are blinded to the dose schedule. Data on adherence to the treatment protocol is monitored using smart pill dispensers. This treatment stage is the longest, lasting 8 months, with participants continuing to complete weekly outcome measures.

After eight months of study capsules, participants will enter a one-month endline phase where no medications are taken. Outcomes will still be completed once per week.

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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07285473 · IRB-300015917 · 1UG3NS141843-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗