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

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

Study Overview

• Status: Withdrawn
• Conditions: Aging
• Intervention / Treatment: Drug: low-dose naltrexone

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • AgelessRx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Eligible long-term (>5 years), intermediate-term (1-5 years), and short-term (<12 months) LDN users

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AgelessRx
• Investigators: Principal Investigator: Sajad Zalzala, MD, AgelessRx

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; low-dose naltrexone; longevity; health status
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: ALRx002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No