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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05307627
Enrollment
0
Registered
2022-04-01
Start date
2022-03-14
Completion date
2023-12-14
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

low-dose naltrexone, longevity, health status, quality of life

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.

Interventions

LDN doses \<20 mg/day

Sponsors

AgelessRx
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
Quality of life scoreAt enrollmentThe 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 StatusAt enrollmentImmune 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

MeasureTime frameDescription
CD4/CD8 ratioAt enrollmentPeripheral blood CD4 vs CD8 T cell ratio in cells/mm3
CMV IgGAt enrollmentPeripheral blood cytomegalovirus (CMV) IgG antibodies in U/mL
hsCRPAt enrollmentPeripheral blood human serum C-reactive protein (hsCRP) concentration in mg/L
General health and family historyAt enrollmentStandard 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.
TNFɑAt enrollmentPeripheral blood serum tumor-necrosis factor alpha (TNFɑ) concentration in pg/L
Methylation age clock testingAt enrollmentDNA methylation array of a blood sample
IL-6At enrollmentPeripheral blood serum interleukin-6 (IL-6) concentration in pg/L
Levine's phenotypic ageAt enrollmentLevine's phenotypic age will be calculated on basis of blood markers for age-associated diseases (glucoregulatory markers, lipids), as well as markers of inflammation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026