What side effects are associated with this type of intervention?

Low-Dose Naltrexone (LDN) is generally well-tolerated, with few side effects. The most commonly reported side effects include vivid dreams, insomnia, and gastrointestinal discomfort. Other treatments for Chronic Fatigue Syndrome that focus on immune modulation and inflammation reduction, such as corticosteroids, may cause side effects like weight gain, hypertension, and increased risk of infections. Non-steroidal anti-inflammatory drugs (NSAIDs) used for pain relief can lead to gastrointestinal issues, cardiovascular risks, and kidney problems. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Chronic Fatigue Syndrome (CFS). However, various treatments have been explored to manage symptoms, including Low-Dose Naltrexone (LDN), which is being studied for its potential to modulate the immune system, reduce inflammation, and improve pain and well-being. Other treatments that have been used off-label or are under investigation include antivirals, immunomodulatory agents, and medications targeting specific symptoms such as pain and sleep disturbances.

What other types of research exist?

Promising alternatives to Low-Dose Naltrexone for Chronic Fatigue Syndrome patients include: 1) Auranofin: Demonstrated significant steroid-sparing effects and reduction in corticosteroid use in asthma patients, which may translate to benefits in CFS by reducing inflammation and modulating the immune system. 2) Anti-interleukin-13/-4 agents: These agents have shown potential in improving asthma control and reducing exacerbations, which may also benefit CFS patients by modulating immune responses and reducing inflammation. 3) Dupilumab: This IL-4 receptor α chain antibody has shown improvements in depressive symptoms and quality of life in asthma patients with eosinophilic chronic rhinosinusitis, suggesting potential benefits in CFS by improving well-being and reducing inflammation.

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Opioid Antagonist

Low-Dose Naltrexone for Post-COVID Fatigue Syndrome

Phase 2

Recruiting

Led By Luis Nacul, MD, PhD

Research Sponsored by Luis Nacul

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Case of SARS-CoV-2 over 3 previously, confirmed by a positive test result or clinical confirmation by a physician

Male and female patients ages 19 to less than 70 years

Must not have

Confirmed ME/CFS or FM existing prior to SARS-CoV-2 infection

Any use of opioid medications within the last 15 days, as reported by the patient

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial tests low-dose naltrexone (LDN) to see if it can reduce fatigue and inflammation in people aged 19-69 who have persistent symptoms after recovering from COVID-19. LDN is a small dose of a medication usually used for addiction, which might help by calming the immune system.

Who is the study for?

This trial is for men and women aged 19-69 who've had COVID-19 at least 3 months ago, meet the criteria for Post-COVID Fatigue Syndrome, and can stay on their current meds. They must not have severe liver or kidney issues, recent naltrexone use, opioid use in the last 15 days, a history of substance misuse, or be pregnant/breastfeeding.

What is being tested?

The study tests if low-dose Naltrexone (1-4.5 mg) helps reduce fatigue and inflammation in those with Post-COVID Fatigue Syndrome compared to a placebo. Participants will either receive LDN or an inactive substance without knowing which one they're getting.

What are the potential side effects?

Low-dose Naltrexone is generally safe but may cause side effects like pain relief and improved mood due to its anti-inflammatory properties. Specific side effects are not listed but could include typical drug reactions such as nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had COVID-19 more than 3 months ago, confirmed by a test or doctor.

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I am between 19 and 69 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had ME/CFS or fibromyalgia before getting COVID-19.

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I have not taken any opioid medications in the last 15 days.

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I do not have acute hepatitis, liver failure, or severe kidney failure.

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I will be using opioid medications during the trial.

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I have used naltrexone in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fatigue Intensity

Secondary study objectives

Activity Levels

Pain Severity

Self-reported Quality of Life

+1 more

Other study objectives

Clinical Endurance/ Hand Grip Strength Parameters

Clinical Endurance/ Sit and Stand Strength Parameters

Exploratory outcome: Anxiety

+12 more

Side effects data

From 2020 Phase 2 trial • 43 Patients • NCT04409041

21%

vivid dreams

headache

Breast cancer

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Group (Low-dose Naltrexone)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low-Dose NaltrexoneExperimental Treatment1 Intervention

The Low-Dose Naltrexone (LDN) will be provided as a compounded capsule starting at a strength of 1mg/day of naltrexone and increasing up to a maximum of 4.5 mg/day. The compounding pharmacy will compound the needed doses in Capsugel® empty gelatin based capsules using Naltrexone Hydrochloride Tablets and CELLULOSE.

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo capsule will be created by compounding pharmacy to look exactly like the LDN doses. The compounding pharmacy will compound the placebo in Capsugel® empty gelatin based capsules using CELLULOSE.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naltrexone

FDA approved

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Fatigue Syndrome (CFS) often aim to modulate the immune system, reduce inflammation, and improve pain and overall well-being. Low-Dose Naltrexone (LDN) is one such treatment being studied for its potential benefits in CFS. LDN works by temporarily blocking opioid receptors, which leads to a rebound effect of increased endorphin and enkephalin production, enhancing the body's natural pain relief and immune response. This modulation of the immune system can reduce chronic inflammation, a key factor in CFS. Additionally, LDN may improve sleep and reduce fatigue, contributing to better overall well-being. These mechanisms are crucial for CFS patients as they address the multifaceted nature of the syndrome, targeting both physical and psychological symptoms.