Stress and Pain in People Living With HIV

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06784908
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 68 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 16, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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)
  • Experimental: 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)
  • Experimental: 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)
  • Experimental: 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)

Primary Outcome Measure

Change in cortisol levels [ Time Frame: day 1 and day 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Yale Stress CenterNew HavenConnecticut06519-

Find similar trials in New Haven, CT

By condition
DepressionHIV
By specialty
PsychiatryMental healthBehavioral healthInfectious disease
By research site
The Yale Stress Center· New Haven, CT

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