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Stress and Pain in People Living With HIV

Stress-immune Mechanisms for People Living With HIV, CUD and Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 68 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at stress and pain in people with and without HIV. It includes people with both cannabis use disorder and major depression, and people without these conditions. Participants complete two sessions of the Yale Pain Stress Task and follow-up checks on drug use and mood.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be in good health based on a screening exam.
  • Be able to read English, complete study tests, and give written and spoken consent.
  • People with HIV must have a positive HIV-1 test, virus levels too low for a test to detect, and take their HIV medicines as directed.
  • HIV plus both conditions group: Have a positive cannabis urine test, cannabis use disorder (cannabis use that causes problems), and major depression.
  • HIV-only group: Have a negative urine drug test and no major medical or mental health diagnoses.
  • Both conditions without HIV group: Have a negative HIV-1 test, a positive urine drug test, cannabis use disorder, and major depression.
  • Healthy comparison group: Have a negative HIV-1 test, a negative urine drug test, and no major medical or mental health diagnoses.

Who can't join

  • Have a current, main diagnosis of another moderate or severe substance use disorder, including cocaine, alcohol, opioids, sedatives, or nicotine.
  • Currently use cocaine or opioids, or have a past cocaine or opioid use disorder.
  • Have ever had a psychotic disorder, which can make it hard to tell what is real.
  • Currently have bipolar disorder or post-traumatic stress disorder (PTSD).
  • Have severe mental health symptoms, such as losing touch with reality, thoughts of suicide or killing others, or current mania (an unusually high or irritable mood with increased energy).
  • Have a serious medical condition that would interfere with taking part, such as a brain, kidney, thyroid, or heart condition.
  • Take medicines known to affect the body's stress hormone system or immune system.
  • Are pregnant, breastfeeding, or using hormonal birth control that affects the body's cortisol stress response.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CT