Anxiety & Depression Association of America

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)	Other: 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.
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)	Other: 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.
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)	Other: 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.
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)	Other: 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Yale University

Study Contact

Rachel Hart, MA
203-737-4791
Rachel.hart@yale.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.