Examining stress and pain in individuals living with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between stress, pain, and substance use in individuals living with HIV and those with cannabis use disorder and major depression. Participants will undergo the Yale Pain Stress Task (YPST) in two sessions, followed by a follow-up phase to assess drug use and mood symptoms. The research aims to explore how stress-related biological mechanisms and epigenetic changes affect mental health and substance use in this population. By employing a cross-diagnostic approach, the study seeks to fill existing research gaps in understanding the complexities of living with HIV and associated morbidities.

Why it matters

Who can join: the full rules

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's running

• The Yale Stress Center
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Rajita Sinha, Ph.D. — Yale University
• Study coordinator: Rachel Hart, MA
• Email: Rachel.hart@yale.edu
• Phone: 203-737-4791

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating the effects of cannabis use and depression in young people living with HIV

  This study is looking at how using cannabis affects depression in young people with HIV to see if there are any patterns that could lead to worse health over a year.

  Recruiting University of Miami · Miami, Florida · NCT05453513

• Expanding access to depression treatment for adults with HIV to improve mood and viral control.

  This project tests whether giving HIV clinics extra training and support helps more adults with HIV and depression start proven depression treatments and reach viral suppression within a year.

  Recruiting University of Miami · Cape Town · NCT07032363

• Improving mental health and HIV care for pregnant women in Malawi

  This study is testing a new support program to see if it can help pregnant women living with HIV in Malawi feel better mentally, engage more with their HIV care, and improve their baby's health.

  Recruiting at 4 sites University of North Carolina, Chapel Hill · Lilongwe and 4 other locations · NCT06702722

• Change My Story: a narrative game plus task-shifted therapy for young people with HIV

  This pilot will test whether the Change My Story interactive narrative game combined with task-shifted Problem Solving Therapy helps 16–24-year-olds living with HIV in Nigeria who have depression or psychological distress improve mood and medication adherence.

  Recruiting Massachusetts General Hospital · Ibadan, Oyo State · NCT06389565

• Investigating the link between inflammation and depression in people with HIV

  This study is testing if an anti-inflammatory drug can help reduce depression symptoms in people with HIV who have high inflammation.

  Recruiting at 2 sites Phase 2 Emory University · Atlanta, Georgia and 1 other locations · NCT05849038

• Smartphone-supported single-session psychotherapy for postpartum depression

  A single online therapy session plus four weeks of app-based support is being tested to see if it reduces depressive symptoms in postpartum women compared with a waitlist.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07925762

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.