Using low-dose naltrexone to treat post-COVID fatigue syndrome
A Double Blind Randomized Trial of Low-dose Naltrexone for Post-COVID Fatigue Syndrome
This study is testing if low-dose naltrexone can help people with post-COVID fatigue feel better and reduce their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 19 Years to 69 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05430152 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of low-dose naltrexone (LDN) in alleviating fatigue and related symptoms in individuals suffering from Post-COVID-19 Fatigue Syndrome (PCFS). Participants will receive either LDN or a placebo, and the study will measure changes in fatigue levels and inflammatory markers in the blood. The research is being conducted by the Complex Chronic Diseases Program at BC Women's Hospital, aiming to provide a potential treatment option for those affected by long-term symptoms following COVID-19 infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 69 who have had a confirmed case of COVID-19 and meet the clinical criteria for PCFS.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of substance misuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from post-COVID fatigue syndrome.
How similar studies have performed: While low-dose naltrexone has shown promise in other conditions, this specific application for post-COVID fatigue syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female patients ages 19 to less than 70 years 2. Case of SARS-CoV-2 over 3 previously, confirmed by a positive test result or clinical confirmation by a physician 3. Meet the clinical diagnostic criteria for PCFS 4. Agree to maintain 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) 5. Agree to use effective contraception for the trial duration, as appropriate, if female. 6. The participant resides within the delivery area for the drug as determined by FedEx Clinical Trial Services Exclusion Criteria: 1. Pregnant, planning to become pregnant, or breastfeeding 2. Opioid medications: * Any use within last 15 days, as reported by the patient * During the trial 3. A positive urine test for opioids (only for the first 16 participants) 4. History of alcohol, opioid or other substance misuse 5. Participation in another interventional clinical trial in the last 30 days or planned during the trial period 6. Confirmed ME/CFS or FM existing prior to SARS-CoV-2 infection 7. Allergy to naltrexone or medication components 8. Acute hepatitis, liver failure, or severe kidney failure. 9. Current or recent use of naltrexone in the last 30 days 10. The participant is not an ideal candidate for the study, in the opinion of the investigator, for any other reason (ie. personal or logistic, medication, condition, etc.) that could impact the participant's safety or the results of the study. Opioid Washout Period: Potential participants who are currently taking opioid medications who wish to enrol the study will be instructed they can stop taking opioid medications for 15 days before continuing the screening process. They will be instructed that they should speak with their family doctor before stopping any prescribed medications. Positive Urine Test for Opioids: As regular use of opioid medications is an exclusion criterion, we will do a quality control check with the first 16 participants to test for the presence of opioids in their urine. Any participants with a positive test, will be excluded from the study, and such finding will be discussed at the Trial Steering Committee or DSMB for potential trial modification.
Where this trial is running
Vancouver, British Columbia
- Women's Health Research Institute — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Luis Nacul, MD, PhD — WHRI / University of British Columbia
- Study coordinator: Travis Boulter
- Email: LDNtrial@phsa.ca
- Phone: 236-990-9519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.