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

Sponsor
AgelessRx (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05307627
Collaborator
(none)
2,500
Enrollment
1
Location
5.6
Anticipated Duration (Months)
450.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging - A Retrospective Cross-sectional Study Into Off-label Use of LDN
Actual Study Start Date :
Mar 14, 2022
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life score [At enrollment]

      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

    2. Immune Status [At enrollment]

      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.

    Secondary Outcome Measures

    1. General health and family history [At enrollment]

      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.

    2. Levine's phenotypic age [At enrollment]

      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

    3. CD4/CD8 ratio [At enrollment]

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

    4. CMV IgG [At enrollment]

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

    5. hsCRP [At enrollment]

      Peripheral blood human serum C-reactive protein (hsCRP) concentration in mg/L

    6. IL-6 [At enrollment]

      Peripheral blood serum interleukin-6 (IL-6) concentration in pg/L

    7. TNFÉ‘ [At enrollment]

      Peripheral blood serum tumor-necrosis factor alpha (TNFÉ‘) concentration in pg/L

    8. Methylation age clock testing [At enrollment]

      DNA methylation array of a blood sample

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AgelessRx Ann Arbor Michigan United States 48104

    Sponsors and Collaborators

    • AgelessRx

    Investigators

    • Principal Investigator: Sajad Zalzala, MD, AgelessRx

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AgelessRx
    ClinicalTrials.gov Identifier:
    NCT05307627
    Other Study ID Numbers:
    • ALRx002
    First Posted:
    Apr 1, 2022
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AgelessRx
    low-dose naltrexone
    longevity
    health status
    quality of life
    Additional relevant MeSH terms:
    Naltrexone

    Study Results

    No Results Posted as of Apr 1, 2022