Stress and Pain in People Living With HIV
Recruiting · NCT06784908 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Yale Pain Stress Task (YPST)
What this trial 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.
Who can take part
Age range
18 Years to 68 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- The Yale Stress Center - New Haven, Connecticut, United States