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

AgelessRx

Overview

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

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.

Study Type

OBSERVATIONAL

Conditions

Aging

Interventions

low-dose naltrexoneDRUG

LDN doses \<20 mg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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)

Locations (1)

AgelessRx

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: At enrollment

Secondary Outcomes

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.

Time frame: 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

Time frame: At enrollment

CD4/CD8 ratio

Peripheral blood CD4 vs CD8 T cell ratio in cells/mm3

Time frame: At enrollment

CMV IgG

Peripheral blood cytomegalovirus (CMV) IgG antibodies in U/mL

Time frame: At enrollment

Data from ClinicalTrials.gov

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