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

The University of Alabama at Birmingham

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07285473

1UG3NS141843 (Other Identifier)

IRB-300015917

Details and patient eligibility

About

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 entire U.S.

Full description

This study uses a remote design where individuals can participate from anywhere in the United States. Study medications will be received by mail. All participants must meet ME-ICC criteria. This study will be tested on participants recruited nationwide, 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 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 weekly using REDCap surveys. 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between ages of 18 and 65
• Living in the United States
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Participants Receiving Low-Dose Naltrexone

Experimental group

Description:

Participants Receiving Low-Dose Naltrexone

Treatment:

Drug: Low-Dose Naltrexone, 1.5mg

Drug: Low-Dose Naltrexone, 6.0mg

Drug: Low-Dose Naltrexone, 4.5mg

Drug: Low-Dose Naltrexone, 3.0mg