Stress and Pain in People Living With HIV (HIV Stress)

Yale University

Status: Enrolling

Conditions: Cannabis Use Disorder; HIV; Depression; Pain; Stress

Treatments: Other: Yale Pain Stress Task (YPST)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06784908

1R01DA061995-01 (U.S. NIH Grant/Contract)

2000038503

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 68 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

HIV-positive (PLWH+)

Experimental group

Description:

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)

Treatment:

Other: Yale Pain Stress Task (YPST)

HIV-positive and complex morbidity (PLWH/CM+)

Experimental group

Description:

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)

Treatment:

Other: Yale Pain Stress Task (YPST)

Healthy control (HC)

Experimental group

Description:

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)

Treatment:

Other: Yale Pain Stress Task (YPST)

Control and complex morbidity (HC+CM)

Experimental group

Description:

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)

Treatment:

Other: Yale Pain Stress Task (YPST)