HIVHIV StressNCT06784908
Stress and Pain in People Living With HIV
A study testing Yale Pain Stress Task (YPST) in people with HIV and Depression, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Depression, Cannabis Use Disorder
- What is being tested?
- Yale Pain Stress Task (YPST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to 31 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 20Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Yale Stress Center
New Haven, Connecticut, 06519
About this study
Official title: Stress-immune Mechanisms for People Living With HIV, CUD and Depression
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.
Read the 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.
- Conditions
- HIV, Depression, Cannabis Use Disorder, Stress, Pain
- Being tested
- Yale Pain Stress Task (YPST)
- Medical subject headings
- Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Other: Yale Pain Stress Task (YPST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: day 1 and day 3
Secondary outcomes (3)
Mean behavioral pain tolerance
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
Measured: day 1 or day 3
Mean Heart Rate
Heart rate (bpm) assessed using repeated sampling over 2 hour period on 2 separate days using standard heart rate monitor.
Measured: day 1 and day 3
Mean Blood pressure (systolic and diastolic)
Blood pressure (mmHg), systolic and diastolic,assessed using repeated sampling over 2 hour period on 2 separate days using standard blood pressure monitor.
Measured: day 1 and day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start16 Jan 2025
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Rajita Sinha, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784908
- Sponsor's protocol ID
- 2000038503
- Other IDs
- 1R01DA061995-01
- Acronym
- HIV Stress
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified data will be uploaded into National Institute of Mental Health Data Archive (NDA) data repository.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-immune Mechanisms for People Living With HIV, CUD and Depression
- ClinicalTrials.gov ID
- NCT06784908
- Acronym / sponsor ID
- HIV Stress / 2000038503
- Conditions
- HIV, Depression, Cannabis Use Disorder, Stress, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV-positive (PLWH+) | Experimental | Other: Yale Pain Stress Task (YPST)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) |
| HIV-positive and complex morbidity (PLWH/CM+) | Experimental | Other: Yale Pain Stress Task (YPST)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) |
| Healthy control (HC) | Experimental | Other: Yale Pain Stress Task (YPST)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) |
| Control and complex morbidity (HC+CM) | Experimental | Other: Yale Pain Stress Task (YPST)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) |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Control and complex morbidity (HC+CM), HIV-positive (PLWH+), HIV-positive and complex morbidity (PLWH/CM+), Healthy control (HC) |
Primary outcome
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.
3 secondary outcomes
Mean behavioral pain tolerance
Time frame: day 1 or day 3
Mean Heart Rate
Time frame: day 1 and day 3
Mean Blood pressure (systolic and diastolic)
Time frame: day 1 and day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual de-identified data will be uploaded into National Institute of Mental Health Data Archive (NDA) data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajita Sinha, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yale Pain Stress Task (YPST) in people with HIV and Depression, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Hart, MA (203-737-4791, Rachel.hart@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortisol levels (time frame: day 1 and day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.