Stress-immune Mechanisms for People Living With HIV, CUD and Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in cortisol levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •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.
- •HIV-1 test positive
- •urine toxicology negative
- •no major medical and psychiatric diagnoses based on DSM-V.
- •HIV-1 test negative
- •urine toxicology positive
- •meet DSM-5 criteria for CUD and MDD as assessed using SCID-I
排除标准
- •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.
研究组 & 干预措施
HIV-positive (PLWH+)
Participants that are HIV-positive only will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)
干预措施: Yale Pain Stress Task (YPST) (Other)
HIV-positive and complex morbidity (PLWH/CM+)
Participants that are HIV-positive with complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)
干预措施: Yale Pain Stress Task (YPST) (Other)
Healthy control (HC)
Participants that are not HIV-positive and no complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)
干预措施: Yale Pain Stress Task (YPST) (Other)
Control and complex morbidity (HC+CM)
Participants that are not HIV-positive and have complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)
干预措施: Yale Pain Stress Task (YPST) (Other)
结局指标
主要结局
Change in cortisol levels
时间窗: day 1 and day 3
Mean change in cortisol levels (pg/ml) assessed using repeated blood sampling over 2 hour period on 2 separate days to extract plasma for cortisol measurement using standard RIA assay procedures.
Change in adrenocorticotropic hormone (ACTH) levels
时间窗: day 1 and day 3
Mean change in pain stress assessed using repeated blood sampling over 2 hour period on 2 separate days to extract plasma for ACTH measurement using standard RIA assay procedures.
Change in pain stress
时间窗: day 1 and day 3
Mean change in pain stress assessed using repeated sampling over 2 hour period on 2 separate days using 10-point visual analog scales (VAS) where 0 is not at all and 10 is the most pain being experienced.
次要结局
- Mean behavioral pain tolerance(day 1 or day 3)
- Mean Heart Rate(day 1 and day 3)
- Mean Blood pressure (systolic and diastolic)(day 1 and day 3)