Stress and Pain in People Living With HIV

Официальное название

Stress-immune Mechanisms for People Living With HIV, CUD and Depression

Обзор

This is a basic human experimental study utilizing 4 groups of individuals with and without HIV and complex morbidities of cannabis use disorder and major depression who will participate in 2 sessions of the Yale Pain Stress Task (YPST) and follow-up phase to assess drug use and mood symptoms.

Подробное описание

This study aims to address research gaps using a powerful and novel cross-diagnostic approach with multiple complementary approaches to examine the overarching hypothesis that PLWH+CM exhibit impaired stress-related HPA and HPA-immune function due to alterations in epigenetic mechanisms, and these stress-related HPA-immune and related epigenetic aberrations predict distress, craving and substance use symptoms underlying PLWH complex morbidities. This hypothesis will be tested using a combined human experimental stress challenge approach with prospective longitudinal assessment of daily distress, and substance use symptoms as well as assessment of chronic stress (C-stress), social determinants of health (SDoH), and resilience in experimental cohorts of PLWH with and without CM and those without HIV with and without CM.

Вмешательства

• Другое Yale Pain Stress Task (YPST)
  Individuals in the experimental cohort will be scheduled for 2 experimental sessions 1-3 days apart. The YPST stress experiment includes a stress and no-stress session (order randomly assigned, counter-balanced across subjects), and involves multiple (up to 3) unpredictable number of consecutive 3-minute trials of ice-bath (stress) or warm-bath (no stress) forearm immersion (stress) with subjective, physiologic endocrine and immune assessments repeated at specified time points.

Первичные конечные точки

• Change in cortisol levels [Срок оценки: day 1 and day 3]
• Change in adrenocorticotropic hormone (ACTH) levels [Срок оценки: day 1 and day 3]
• Change in pain stress [Срок оценки: day 1 and day 3]

Вторичные конечные точки (3)

• Mean behavioral pain tolerance [Срок оценки: day 1 or day 3]
• Mean Heart Rate [Срок оценки: day 1 and day 3]
• Mean Blood pressure (systolic and diastolic) [Срок оценки: day 1 and day 3]

Критерии участия

Критерии включения

• good health as verified by screening examination
• Able to read English and complete study evaluations and provide informed written and verbal consent. Additional criteria PLWH
• HIV-1 lab test positive
• undetectable viral load
• good ART adherence

Additional criteria by group:

PLWH +CM:

• CB positive urine toxicology
• meet DSM-5 criteria for CUD and MDD as assessed using SCID-I. HC
• HIV-1 test negative
• urine toxicology negative
• no major medical and psychiatric diagnoses based on DSM-V.

PLWH Only:

• HIV-1 test positive
• urine toxicology negative
• no major medical and psychiatric diagnoses based on DSM-V.

CM Only:

• HIV-1 test negative
• urine toxicology positive
• meet DSM-5 criteria for CUD and MDD as assessed using SCID-I

Критерии исключения

• meet primary, current moderate and severe criteria for other SUD including cocaine, alcohol, opiates, sedatives, nicotine
• current use or past history of cocaine or opioid use disorder
• history of any psychotic disorder
• current diagnoses of bipolar disorder and PTSD
• psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania)
• significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology that would interfere with study participation
• medications with known central effects on HPA axis and cytokines/immune function
• women who are pregnant, nursing or those using hormonal birth control that affect HPA axis cortisol responses.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• The Yale Stress Center — New Haven

Идентификаторы

NCT: NCT06784908 · 2000038503 · 1R01DA061995-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗