The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging
- Registration Number
- NCT05307627
- Lead Sponsor
- AgelessRx
- Brief Summary
This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- LDN doses over 20 mg/day
- Terminal cancer patients (defined as stage IV and/or with a life expectancy of 12 months or less)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Long-term (>5 years) LDN users low-dose naltrexone Participants who have been using LDN for over 5 years short-term (<12 months) LDN users low-dose naltrexone Participants who have been using LDN for less than a year. This group will serve as the control group. intermediate-term (1-5 years) LDN users low-dose naltrexone Participants who have been using LDN for at least 1 year, but shorter than 5 years.
- Primary Outcome Measures
Name Time Method Quality of life score At enrollment 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
Immune Status At enrollment 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.
- Secondary Outcome Measures
Name Time Method CMV IgG At enrollment Peripheral blood cytomegalovirus (CMV) IgG antibodies in U/mL
General health and family history At enrollment 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.
Levine's phenotypic age At enrollment 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
CD4/CD8 ratio At enrollment Peripheral blood CD4 vs CD8 T cell ratio in cells/mm3
hsCRP At enrollment Peripheral blood human serum C-reactive protein (hsCRP) concentration in mg/L
IL-6 At enrollment Peripheral blood serum interleukin-6 (IL-6) concentration in pg/L
TNFɑ At enrollment Peripheral blood serum tumor-necrosis factor alpha (TNFɑ) concentration in pg/L
Methylation age clock testing At enrollment DNA methylation array of a blood sample
Trial Locations
- Locations (1)
AgelessRx
🇺🇸Ann Arbor, Michigan, United States