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

NCT05307627 | Withdrawn FDA Drug

• 1 other identifier: ALRx002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aging

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• General health and family history

  At enrollment

• Levine's phenotypic age

  At enrollment

• CD4/CD8 ratio

  At enrollment

• CMV IgG

  At enrollment

• hsCRP

  At enrollment

Study Arms (3)

Long-term (>5 years) LDN users

Participants who have been using LDN for over 5 years

Drug: low-dose naltrexone

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

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

Interventions

low-dose naltrexone DRUG

LDN doses \<20 mg/day

Also known as: LDN

Long-term (>5 years) LDN users; intermediate-term (1-5 years) LDN users; short-term (<12 months) LDN users

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• LDN doses over 20 mg/day
• Terminal cancer patients (defined as stage IV and/or with a life expectancy of 12 months or less)

Sponsors & Collaborators

• AgelessRx: lead

Study Sites (1)

AgelessRx

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Interventions

Naltrexone

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sajad Zalzala, MD

  AgelessRx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 1, 2022
• Study Start: March 14, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)