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Low-dose Naltrexone for Post-COVID Fatigue Syndrome

NCT05430152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-03-20

No results posted yet for this 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). 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 will demonstrate whether LDN could benefit a large number of people with PCFS.

Conditions

  • Post-Viral Fatigue Syndrome

Interventions

DRUG

Low-Dose Naltrexone

Study drug dosing schedule (LDN): * Week 1: 1 mg/day (1 mg cap) * Week 2: 2 mg/day (two 1 mg caps) * Week 3: 3 mg/day (three 1mg caps) * Weeks 4-6: 4.5 mg/day (three 1 mg caps, plus one 1.5 mg cap = 4.5 mg/day) * Weeks 7-16: 4.5 mg/day (one 4.5 mg cap) OR based on self-titration dosage (one 1mg, 2mg, or 3mg cap)

OTHER

Placebo

Study drug dosing schedule (Placebo; capsules made to match LDN doses): * Week 1: 1 mg/day (1 mg cap) * Week 2: 2 mg/day (two 1 mg caps) * Week 3: 3 mg/day (three 1mg caps) * Weeks 4-6: 4.5 mg/day (three 1 mg caps, plus one 1.5 mg cap = 4.5 mg/day) * Weeks 7-16: 4.5 mg/day (one 4.5 mg cap) OR based on self-titration dosage (one 1mg, 2mg, or 3mg cap)

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Provincial Health Services Authority British Columbia

    collaborator OTHER

  • Women's Health Research Institute of British Columbia

    collaborator OTHER

  • Luis Nacul

    lead OTHER

Principal Investigators

  • Luis Nacul, MD, PhD · WHRI / University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2026-02-15
Completion
2026-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05430152 on ClinicalTrials.gov