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Stimulant Use and Methylation in HIV

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ClinicalTrials.gov Identifier: NCT05916989
Recruitment Status : Completed
First Posted : June 23, 2023
Last Update Posted : November 2, 2023
Sponsor:
Collaborators:
New York University
Northwestern University
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Adam Carrico, PhD, Florida International University

Study Description
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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
HIV Infections Methamphetamine-dependence Methamphetamine Abuse

Study Design
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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 : September 30, 2018
Actual Primary Completion Date : October 26, 2022
Actual Study Completion Date : October 26, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Sexual Minority Men - gay, bisexual, and other men who have sex with men.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sexual minority men with HIV who use methamphetamine residing in the San Francisco Bay Area.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05916989


Locations
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United States, Florida
Florida International University
Miami, Florida, United States, 33199
Sponsors and Collaborators
Florida International University
New York University
Northwestern University
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Adam W Carrico, PhD Florida International University
More Information
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Responsible Party: Adam Carrico, PhD, Professor and Chair, Florida International University
ClinicalTrials.gov Identifier: NCT05916989    
Other Study ID Numbers: 20180865
R01DA033854 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2023    Key Record Dates
Last Update Posted: November 2, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adam Carrico, PhD, Florida International University:
HIV
Methamphetamine
Methylation
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases