Stress and Pain in People Living With HIV

Not Applicable

Recruiting

• Conditions: HIV; Depression; Cannabis Use Disorder; Stress; Pain

• Registration Number: NCT06784908
• Lead Sponsor: Yale University

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.

Detailed 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.

Study Timeline

• Study Start: 2025-01-16
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2030-01-31
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in cortisol levels	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.
Change in adrenocorticotropic hormone (ACTH) levels	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.
Change in pain stress	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 Outcome Measures

Name	Time	Method
Mean behavioral pain tolerance	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
Mean Heart Rate	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.
Mean Blood pressure (systolic and diastolic)	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.

Trial Locations

Locations (1)

The Yale Stress Center; 🇺🇸 New Haven, Connecticut, United States