Examining stress and pain in individuals living with HIV
Stress-immune Mechanisms for People Living With HIV, CUD and Depression
This study is testing how stress and pain affect people living with HIV, especially those who also struggle with substance use and depression, to see how these factors are connected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 68 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06784908 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals living with HIV who also have cannabis use disorder and major depression, as well as healthy controls.
Not a fit: Patients with severe substance use disorders other than cannabis or those with major psychiatric diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved interventions for managing stress and pain in individuals living with HIV and related conditions.
How similar studies have performed: Other studies have shown success in exploring the interplay between stress, pain, and substance use in similar populations, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.