Stress and Pain in People Living With HIV
Purpose
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.
Conditions
- HIV
- Depression
- Cannabis Use Disorder
- Stress
- Pain
Eligibility
- Eligible Ages
- Between 18 Years and 68 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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) |
|
|
Experimental 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) |
|
|
Experimental 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) |
|
|
Experimental 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) |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Yale University
Detailed Description
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.
