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NCT Number: NCT06784908

Stress and Pain in People Living With HIV

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.

Recruiting

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Key information

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Yale Stress Center

New Haven, Connecticut, 06519, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yale Pain Stress Task (YPST)

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.

Primary outcomes

  1. Change in cortisol levels

    Time frame: day 1 and day 3

    Mean change in cortisol levels (pg/ml) assessed using repeated blood sampling over 2 hour period on 2 separate days to extract plasma for cortisol measurement using standard RIA assay procedures.

  2. Change in adrenocorticotropic hormone (ACTH) levels

    Time frame: day 1 and day 3

    Mean change in pain stress assessed using repeated blood sampling over 2 hour period on 2 separate days to extract plasma for ACTH measurement using standard RIA assay procedures.

  3. Change in pain stress

    Time frame: day 1 and day 3

    Mean change in pain stress assessed using repeated sampling over 2 hour period on 2 separate days using 10-point visual analog scales (VAS) where 0 is not at all and 10 is the most pain being experienced.

Secondary outcomes

  1. Mean behavioral pain tolerance

    Time frame: day 1 or day 3

    Time in seconds that hand remains immersed in ice cold and warm water over 3 trials of 3 minutes each as a measure of behavioral pain tolerance

  2. Mean Heart Rate

    Time frame: day 1 and day 3

    Heart rate (bpm) assessed using repeated sampling over 2 hour period on 2 separate days using standard heart rate monitor.

  3. Mean Blood pressure (systolic and diastolic)

    Time frame: day 1 and day 3

    Blood pressure (mmHg), systolic and diastolic,assessed using repeated sampling over 2 hour period on 2 separate days using standard blood pressure monitor.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Hart, MA

CONTACT

[email protected]

203-737-4791

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: HIV Stress

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 20, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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