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
Griffith University
56 participants
Apr 1, 2024
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
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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 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).
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ACTRN12623001042639