Low-Dose Naltrexone for Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
BC Women's Hospital + Health Centre, Vancouver, Canada
Syndrome+3 More
Low-Dose Naltrexone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study aims to determine if low-dose naltrexone (LDN) reduces fatigue, improves related symptoms, and reduces inflammatory markers in peripheral blood in cases with Post-COVID-19 Fatigue Syndrome (PCFS) from COVID-19 (i.e. confirmed SARS-CoV-2 case) in the past 3-6 months. LDN refers to naltrexone given in doses of 1-4.5 mg. Overall, studies have found that LDN is safe and well-tolerated. It may help to reduce pain and inflammation and improve well-being and immune function.The trial will be conducted by the Complex Chronic Diseases Program (CCDP) at BC Women's Hospital and the Post-COVID Recovery Clinics (PCRC) in British Columbia and will demonstrate whether LDN could benefit a large number of people with PCFS.

Eligible Conditions

  • Syndrome
  • Post-Viral Fatigue Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 weeks and 16 weeks

12 weeks
Clinical Endurance/ Strength Parameters
Exploratory outcome: Changes in inflammatory marker values in peripheral blood
Exploratory outcome: Disease Severity
Exploratory outcome: Prevalence markers of Postural Orthostatic Tachycardia Syndrome (POTS) or Postural Hypotension
Exploratory outcome: Reverse triiodothyronine (rT3) profile (as an indirect marker of disease severity)
Self-reported Quality of Life.
Week 16
Exploratory outcome: Anxiety
Exploratory outcome: Depression
Exploratory outcome: Self-reported Health
Exploratory outcome: Sleep
Exploratory outcome: Visual Analogue Scale (VAS) Fatigue Score
Fatigue Intensity
Pain Severity
Symptom Severity

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Treatment Group (Low-dose Naltrexone)
21%vivid dreams
9%headache
6%Breast cancer
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT04409041) in the Treatment Group (Low-dose Naltrexone) ARM group. Side effects include: vivid dreams with 21%, headache with 9%, Breast cancer with 6%.

Trial Design

2 Treatment Groups

Low-Dose Naltrexone
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

160 Total Participants · 2 Treatment Groups

Primary Treatment: Low-Dose Naltrexone · Has Placebo Group · Phase 2

Low-Dose Naltrexone
Drug
Experimental Group · 1 Intervention: Low-Dose Naltrexone · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-Dose Naltrexone
2019
Completed Phase 3
~140

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks and 16 weeks
Closest Location: BC Women's Hospital + Health Centre · Vancouver, Canada
Photo of Vancouver  1Photo of Vancouver  2Photo of Vancouver  3
2021First Recorded Clinical Trial
2 TrialsResearching Syndrome
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You agree to use effective contraception for the trial duration, as appropriate, if female.
You agree to take any other regular medications at current doses for the duration of the trial (except for essential need of new medication or dose change, as prescribed by a physician).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.