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

Post COVID-19 Condition

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

Inclusion Criteria2

Participants with long COVID according to the World Health Organization working case definition (Individuals with a history of probable or confirmed SARS-CoV-2 (COVID-19) three months from COVID-19 onset with symptoms lasting at least two months).
Present with symptoms including cognitive disturbances (brain fog), sleep disturbances, and/or body pain.

Exclusion Criteria16

i. Current respiratory infections
ii. Intercurrent SARS-CoV-2 reinfection during trial period (this will be considered drop-out)
iii. Previous clinical diagnosis of ME/CFS
iv. Chronic pain history prior to long COVID onset
v. Adverse reaction to LDN or compounded constituents
vi. Chronic opioid or substitution therapy
vii. Daily opioid use in three months prior to, or during trial
viii. Substance abuse, dependence, addiction
ix. History of drug, alcohol abuse and recreational drugs
x. Pregnancy or breastfeeding
xi. Renal dysfunction (eGFR greater than 30 ml/min/1.73m2), liver dysfunction (ALT or AST greater than 300 IU/L).
xii. Active cancer.
xiii. Inflammatory (rheumatological, GIT, dermatological) or neurological condition (demyelinating).
xiv. Neuroimmune modulators: DMARDs, steroids, minocycline, metformin.
xv. History of anxiety, depression and/or other psychiatric concerns.
xvi. Language, cognition, no computer literacy.

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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).