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Stimulant Use and Methylation in HIV

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT05916989
Collaborator
New York University (Other), Northwestern University (Other), University of California, San Francisco (Other), National Institute on Drug Abuse (NIDA) (NIH)
53
Enrollment
1
Location
48.9
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will leverage extracted leukocyte DNA specimens from a completed NIH-funded project to examine the efficacy of a behavioral intervention model that reduced stimulant use on DNA methylation over 6 months.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    53 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Stimulant Use and Methylation in HIV
    Actual Study Start Date :
    Sep 30, 2018
    Actual Primary Completion Date :
    Oct 26, 2022
    Actual Study Completion Date :
    Oct 26, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Leukocyte DNA Samples

    Leukocyte DNA specimens extracted from participants enrolled in a completed NIH funded trial will be examined to determine if prior exposure to different behavioral interventions modifies DNA methylation patterns over 6 months.

    Outcome Measures

    Primary Outcome Measures

    1. Neuroimmune Signaling [6 Months]

      Decreased methylation of genes for genes relevant to neuroimmune signaling such as beta-2 (β2) adrenergic (i.e., ADRB2), glucocorticoid (i.e., NR3C1 and FKBP5), and oxytocin (i.e., OXTR) receptors as well as brain-derived neurotrophic factor (BDNF) promoters.

    Secondary Outcome Measures

    1. DNA Methylation Pathways [6 Months]

      Pathway Analyses examining alterations in methylation patterns relevant to immune and neural function.

    2. Immune Dysfunction [6 Month]

      Soluble makers of monocyte activation such as soluble CD14 (sCD14) and inflammation such as soluble Tumor Necrosis Factor - Alpha Receptors I and II (sTNF-aRI and sTNF-aRII)

    3. Dysregulated Metabolism of Amino Acid Precursors for Neurotransmitters measured via high-performance liquid chromatography (HPLC) [6 Months]

      Using HPLC, higher kynurenine/tryptophan (K/T) ratio indexes catabolism of tryptophan into kynurenine and other downstream catabolites versus serotonin over 6 months. Using HPLC, the phenylalanine/tyrosine ratio reflects decreased metabolism of tyrosine into catecholamines such as dopamine over 6 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • At least 18 years old

    • Documentation of HIV-positive serostatus

    • Speak English

    • Biological verification of recent methamphetamine use

    • Completion of at least three contingency management (CM) visits

    • Self reported anal sex with a man in the past 12 months

    Exclusion Criteria:

    • Inability to provide informed consent, evidenced by cognitive impairment

    • HIV negative serostatus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami
    • New York University
    • Northwestern University
    • University of California, San Francisco
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Adam W Carrico, PhD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Adam Carrico, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT05916989
    Other Study ID Numbers:
    • 20180865
    • R01DA033854
    First Posted:
    Jun 23, 2023
    Last Update Posted:
    Jun 23, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Adam Carrico, Professor, University of Miami
    HIV
    Methamphetamine
    Methylation
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Jun 23, 2023