NCT06784908 · Yale University
Stress and Pain in People Living With HIV
(HIV Stress)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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 measures
Change in cortisol levels
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New Haven, Connecticut
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations