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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA061995-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day 1 or day 3 |
| Mean Heart Rate |
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Inclusion Criteria:
Additional criteria by group:
PLWH +CM:
PLWH Only:
CM Only:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Hart, MA | Contact | 203-737-4791 | Rachel.hart@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rajita Sinha, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Yale Stress Center | Recruiting | New Haven | Connecticut | 06519 | United States |
Individual de-identified data will be uploaded into National Institute of Mental Health Data Archive (NDA) data repository.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Heart rate (bpm) assessed using repeated sampling over 2 hour period on 2 separate days using standard heart rate monitor.
| 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. | day 1 and day 3 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |