Cannabis Use Disorder, Depression, HIV, Pain, Stress
Conditions
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.
Interventions
OTHERYale 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.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTRachel Hart, MA
PRINCIPAL_INVESTIGATORRajita Sinha, Ph.D.
Yale University
Outcome results
None listed