Stress and Pain in People Living With HIV

Last updated: February 19, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Depression

Hiv

Treatment

Yale Pain Stress Task (YPST)

Clinical Study ID

NCT06784908
2000038503
1R01DA061995-01
  • Ages 18-68
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • good health as verified by screening examination

  • Able to read English and complete study evaluations and provide informed written andverbal 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

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 orcardiac 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 affectHPA axis cortisol responses.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Yale Pain Stress Task (YPST)
Phase:
Study Start date:
January 16, 2025
Estimated Completion Date:
January 31, 2030

Study 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.

Connect with a study center

  • The Yale Stress Center

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

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