RecruitingPhase 1ACTRN12623001042639

Low Dose Naltrexone for the treatment of long COVID-19

Efficacy of Low Dose Naltrexone for the treatment of symptoms of Post COVID-19 Condition


Sponsor

Griffith University

Enrollment

56 participants

Start Date

Apr 1, 2024

Study Type

Interventional

Conditions

Summary

Naltrexone (NTX) is an opioid receptor antagonist commonly used to treat opioid withdrawal at a dose of 50.0-100.0 mg daily. Low dose NTX (LDN), within a specific dosage window of 1-5 mg/day as been used off-label since the mid-1980s due to improvements in chronic pain, stamina, cognition, fatigue, and inflammation for many autoimmune disorders, chronic pain syndromes, malignancies, and mental health disorders to target symptoms overlapping with long COVID. There is evidence to suggest the use of LDN will be beneficial to treat patient outcomes for those with Long COVID. A randomised dose ranging double blind placebo controlled 12-week clinical trial is proposed to determine the efficacy of LDN based on clinical symptoms and quality of life. Primary and secondary outcomes will be assessed through a series of online questionnaires to determine changes in symptom presentation (primary outcome) and through a series of validated patient reported outcome measures for quality of life.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Long COVID — the persistence of debilitating symptoms for months after a COVID-19 infection — can include brain fog, fatigue, sleep problems, and chronic pain. For many people, these symptoms significantly interfere with work and daily life, and there are currently few proven treatments. This trial is investigating whether low dose naltrexone (LDN), a medication typically used at high doses for opioid addiction but used off-label at very low doses for pain and inflammatory conditions, can help. In this 12-week double-blind placebo-controlled trial, participants with long COVID will receive either LDN (at one of several low doses) or a placebo. Researchers will track changes in cognitive symptoms, sleep, body pain, and quality of life. All assessments are completed through online questionnaires, making participation accessible from home. You may be eligible if you are aged 18–65, were diagnosed with COVID-19 at least three months ago, still have symptoms including brain fog, sleep disturbance, or body pain, and do not currently use opioid medications. People with pre-existing chronic pain, ME/CFS, active cancer, certain inflammatory conditions, or history of anxiety or depression are not eligible. The study is run by Griffith University.

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Interventions

Active agent: Naltrexone Hydrochloride at low doses (low dose naltrexone [LDN], 3-6mg/day). Ingredients: Cellulose and Hypromellose Description: white to off-white capsules. Storage: Store medici

Active agent: Naltrexone Hydrochloride at low doses (low dose naltrexone [LDN], 3-6mg/day). Ingredients: Cellulose and Hypromellose Description: white to off-white capsules. Storage: Store medicine in a cool dry place where the temperature will stay below 25oC. Administration: Orally, once per day preferably at night for 12 weeks. Doses: dose escalation will commence from week 1 for approximately 3 to 4 weeks. All participants will start at 1.5mg/day and will increase their dose by 1.5mg/day until their maximum dose is reached (target 4-6mg/day). Maximum dose will be monitored by study clinicians as the maximum tolerated dose. LDN at differing doses will be distributed using different coloured labels/lids. Protocol compliance: investigational product will be return at the end of the study for pill counts, in addition to online questionnaire (diary).


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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