RecruitingNot ApplicableNCT06784908

Stress and Pain in People Living With HIV

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

Sponsor

Yale University

Enrollment

120 participants

Start Date

Jan 16, 2025

Study Type

INTERVENTIONAL

Conditions

Pain Depression Stress HIV Cannabis Use Disorder

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 68 Years

Inclusion Criteria20

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 Criteria8

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.

Interventions

OTHERYale 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.