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Completed

NCT Number: NCT05916989

Stimulant Use and Methylation in HIV

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Methamphetamine Abuse Methamphetamine-dependence RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Florida International University

Miami, Florida, 33199, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neuroimmune Signaling

    Time frame: 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 outcomes

  1. DNA Methylation Pathways

    Time frame: 6 Months

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

  2. Immune Dysfunction

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2023
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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