Stress and Pain in People Living With HIV

NCT06784908 | Recruiting

• 2 other identifiers: 20000385031R01DA061995-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in cortisol levels

  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.

  day 1 and day 3

• Change in adrenocorticotropic hormone (ACTH) levels

  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.

  day 1 and day 3

• Change in pain stress

  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.

  day 1 and day 3

Secondary Outcomes (3)

• Mean behavioral pain tolerance

  day 1 or day 3

• Mean Heart Rate

  day 1 and day 3

• Mean Blood pressure (systolic and diastolic)

  day 1 and day 3

Study Arms (4)

HIV-positive (PLWH+)

EXPERIMENTAL

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)

Other: Yale Pain Stress Task (YPST)

HIV-positive and complex morbidity (PLWH/CM+)

EXPERIMENTAL

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)

Other: Yale Pain Stress Task (YPST)

Healthy control (HC)

EXPERIMENTAL

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)

Other: Yale Pain Stress Task (YPST)

Control and complex morbidity (HC+CM)

EXPERIMENTAL

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)

Other: Yale Pain Stress Task (YPST)

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.

Control and complex morbidity (HC+CM); HIV-positive (PLWH+); HIV-positive and complex morbidity (PLWH/CM+); Healthy control (HC)

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Yale Stress Center

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Depression; Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajita Sinha, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Hart, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 20, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)