Stimulant Use and Methylation in HIV

Completed

• Conditions: Methamphetamine Abuse; HIV Infections; Methamphetamine-dependence

• Registration Number: NCT05916989
• Lead Sponsor: Florida International University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-30
• Primary Completion: 2022-10-26
• Study Completion: 2022-10-26
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
DNA Methylation Pathways	6 Months	Pathway Analyses examining alterations in methylation patterns relevant to immune and neural function.
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)
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.

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States