Stress and Pain in People Living With HIV

NCT ID: NCT06784908

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2030-01-31

Brief 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.

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.

Conditions

HIV; Depression; Cannabis Use Disorder; Stress; Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Yale Pain Stress Task (YPST)

Intervention Type: OTHER

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.

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)

Group Type: EXPERIMENTAL

Yale Pain Stress Task (YPST)

Intervention Type: OTHER

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.

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)

Group Type: EXPERIMENTAL

Yale Pain Stress Task (YPST)

Intervention Type: OTHER

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.

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)

Group Type: EXPERIMENTAL

Yale Pain Stress Task (YPST)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajita Sinha, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

The Yale Stress Center

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Hart, MA

Role: CONTACT

Rachel.hart@yale.edu

203-737-4791

Other Identifiers

1R01DA061995-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000038503

Identifier Type: -

Identifier Source: org_study_id