Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06784908

Conditions

HIV

Depression

Cannabis Use Disorder

Stress

Pain

Eligibility Criteria

Sex: All

Age: 18 - 68

Healthy Volunteers: Accepted

Interventions

Yale Pain Stress Task (YPST)

Study Details

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.

Conditions

HIV

Depression

Cannabis Use Disorder

Stress

Pain

Study ID

NCT06784908

Start date

Jan 16, 2025

Status verified date

Apr, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 68

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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)

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.

Primary outcome measure

  • Change in cortisol levels [ Time Frame: day 1 and day 3 ]
  • Change in adrenocorticotropic hormone (ACTH) levels [ Time Frame: day 1 and day 3 ]
  • Change in pain stress [ Time Frame: day 1 and day 3 ]

Central Contacts and Locations

Central contacts

Rachel Hart, MA

203-737-4791Rachel.hart@yale.edu

Locations

The Yale Stress Center

Recruiting

New Haven, Connecticut, United States, 06519

More Information

Sponsor

Yale University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-04-27.