Clinical trial NCT06784908: Stress and Pain in People Living With HIV
Official title: Stress-immune Mechanisms for People Living With HIV, CUD and Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Depression
Cannabis Use Disorder
Stress
Pain
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in cortisol levels
timeFrame: day 1 and day 3
measure: Change in adrenocorticotropic hormone (ACTH) levels
timeFrame: day 1 and day 3
measure: Change in pain stress
timeFrame: day 1 and day 3
Secondary outcomes:
measure: Mean behavioral pain tolerance
timeFrame: day 1 or day 3
measure: Mean Heart Rate
timeFrame: day 1 and day 3
measure: Mean Blood pressure (systolic and diastolic)
timeFrame: day 1 and day 3
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The Yale Stress Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Rajita Sinha, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: