The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging

Study Overview
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Brief Summary
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This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users.

Detailed Description
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Long-term (>5 years), intermediate-term (1-5 years), and short-term low-dose naltrexone (LDN) users (<12 months) will be contacted for a retrospective, observational assessment of their health status. Participants will be asked to complete a series of questionnaires assessing their quality of life, general physical and mental health, family history, the occurrence of age-related diseases, and immune status. Additionally, blood tests for immune and longevity markers will be optional for a subset of participants.

Official Title
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The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging - A Retrospective Cross-sectional Study Into Off-label Use of LDN

Conditions
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Aging

Intervention / Treatment
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* Drug: low-dose naltrexone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (aged 18-120) Any sex Any ethnicity Taking LDN Willing to complete health questionnaires Technologically competent to complete web forms Subgroup: willing to undergo blood testing Exclusion Criteria: LDN doses over 20 mg/day Terminal cancer patients (defined as stage IV and/or with a life expectancy of 12 months or less)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long-term (>5 years) LDN users<br>Participants who have been using LDN for over 5 years | Drug: low-dose naltrexone<br>* LDN doses <20 mg/day<br>* Other names: LDN;|
| intermediate-term (1-5 years) LDN users<br>Participants who have been using LDN for at least 1 year, but shorter than 5 years. | Drug: low-dose naltrexone<br>* LDN doses <20 mg/day<br>* Other names: LDN;|
| short-term (<12 months) LDN users<br>Participants who have been using LDN for less than a year. This group will serve as the control group. | Drug: low-dose naltrexone<br>* LDN doses <20 mg/day<br>* Other names: LDN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | The short-form (SF)-36 Questionnaire generates scores in the categories: physical function, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Scores up to maximum 100, with higher scores representing better quality of life | At enrollment | 
| Immune Status | Immune Status Questionnaire (ISQ) to define a measure of perceived immune status, consists of seven representative immune-associated symptoms and diseases. The Immune Status Questionnaire scores respondents out of 10, with 10 being a better outcome and lower scores worse outcome. | At enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health and family history | Standard questions assessing family history, and information about the dosing, duration of use, reasons for taking LDN, age, sex, weight, length, smoking and alcohol use history, substance abuse history, physical activity, other medications, and side effects of the drug, and other questions related to health and medical history. | At enrollment | 
| Levine's phenotypic age | Levine's phenotypic age will be calculated on basis of blood markers for age-associated diseases (glucoregulatory markers, lipids), as well as markers of inflammation | At enrollment | 
| CD4/CD8 ratio | Peripheral blood CD4 vs CD8 T cell ratio in cells/mm3 | At enrollment | 
| CMV IgG | Peripheral blood cytomegalovirus (CMV) IgG antibodies in U/mL | At enrollment | 
| hsCRP | Peripheral blood human serum C-reactive protein (hsCRP) concentration in mg/L | At enrollment | 
| IL-6 | Peripheral blood serum interleukin-6 (IL-6) concentration in pg/L | At enrollment | 
| TNFɑ | Peripheral blood serum tumor-necrosis factor alpha (TNFɑ) concentration in pg/L | At enrollment | 
| Methylation age clock testing | DNA methylation array of a blood sample | At enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-dose naltrexone, longevity, health status, quality of life