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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will study whether low-dose naltrexone can help with symptoms of Post-COVID-19 Fatigue Syndrome. LDN is a medication that is given in doses of 1-4.5 mg and is safe and well-tolerated. It may help to reduce pain and inflammation and improve well-being and immune function.

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.Check my eligibility
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.See study design
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
Select...
I had COVID-19 more than 3 months ago, confirmed by a test or doctor.
Select...
I am between 19 and 69 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue Intensity
Secondary outcome measures
Activity Levels
Pain Severity
Self-reported Quality of Life
+1 more
Other outcome measures
Clinical Endurance/ Strength Parameters
Exploratory outcome: Anxiety
Exploratory outcome: Changes in inflammatory marker values in peripheral blood
+10 more

Side effects data

From 2020 Phase 2 trial • 43 Patients • NCT04409041
21%
vivid dreams
9%
headache
6%
Breast cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group (Low-dose Naltrexone)

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

Find a Location

Who is running the clinical trial?

Vancouver Island Health AuthorityOTHER
16 Previous Clinical Trials
4,432 Total Patients Enrolled
Fraser HealthOTHER
45 Previous Clinical Trials
707,330 Total Patients Enrolled
Vancouver Coastal HealthOTHER_GOV
37 Previous Clinical Trials
711,752 Total Patients Enrolled

Media Library

Low-Dose Naltrexone (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05430152 — Phase 2
Low-Dose Naltrexone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05430152 — Phase 2
Chronic Fatigue Syndrome Research Study Groups: Low-Dose Naltrexone, Placebo
Chronic Fatigue Syndrome Clinical Trial 2023: Low-Dose Naltrexone Highlights & Side Effects. Trial Name: NCT05430152 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment accept participants under the age of 30?

"As specified in the trial's eligibility guidelines, 19 is the lowest age of admission while 69 marks the upper limit."

Answered by AI

Are there any existing opportunities to become involved in this research endeavor?

"Clinicaltrials.gov reports that this research is not presently enrolling patients; the trial was first posted on March 1st 2023 and last updated December 6th 2022. Nevertheless, 1617 other clinical trials are actively seeking participants as of now."

Answered by AI

Can I be included in this exploration?

"This medical trial requires 160 participants, aged between 19 and 69 years old who have the specified syndrome. For eligibility in this study, individuals must accept contraception for its duration if female, maintain regular medications dose unless essential changes are prescribed by a doctor, verify SARS-CoV-2 case status within 3 to 6 months of recruitment through testing or clinical confirmation from a physician, and meet all relevant diagnostic criteria as authenticated by PCRC."

Answered by AI

Is Low-Dose Naltrexone sanctioned by the FDA?

"Despite the lack of efficacy data, Low-Dose Naltrexone is thought to be relatively safe and thus was assigned a rating of 2."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Low-dose Naltrexone for Post-COVID Fatigue Syndrome
Luis Nacul 2024. "Low-dose Naltrexone for Post-COVID Fatigue Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05430152.
All > Me Cfs > Chronic Fatigue Syndrome
~107 spots leftby Dec 2024
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