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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05307627
• Other study ID #: ALRx002
• Status: Suspended
• Start date: March 14, 2022
• Est. completion date: December 14, 2023

Study information

• Verified date: July 2023
• Source: AgelessRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Suspended
• Enrollment: 2500
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• low-dose naltrexone
LDN doses <20 mg/day

Locations

Country	Name	City	State
United States	AgelessRx	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AgelessRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	CD4/CD8 ratio	Peripheral blood CD4 vs CD8 T cell ratio in cells/mm3	At enrollment
Secondary	CMV IgG	Peripheral blood cytomegalovirus (CMV) IgG antibodies in U/mL	At enrollment
Secondary	hsCRP	Peripheral blood human serum C-reactive protein (hsCRP) concentration in mg/L	At enrollment
Secondary	IL-6	Peripheral blood serum interleukin-6 (IL-6) concentration in pg/L	At enrollment
Secondary	TNF?	Peripheral blood serum tumor-necrosis factor alpha (TNF?) concentration in pg/L	At enrollment
Secondary	Methylation age clock testing	DNA methylation array of a blood sample	At enrollment