Stress Task for People With HIV

(HIV Stress Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Rajita Sinha, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

Must not be taking: Hormonal birth control

Disqualifiers: Cocaine, Opioid use disorder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that affect the HPA axis (a system that controls stress responses) and immune function. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Yale Pain Stress Task (YPST) for people with HIV?

The research suggests that addressing affective symptoms, such as anxiety and depression, may help manage pain in people with HIV. Since the Yale Pain Stress Task (YPST) is likely designed to address stress and pain, it may be beneficial in reducing pain-related anxiety and improving overall pain management in this population. ^{1 2 3 4 5}

Is the Stress Task for People With HIV safe for humans?

The cold pressor test, a similar stress task, was used in a study with both HIV-positive and HIV-negative participants and showed consistent responses without significant differences in immune responses, anxiety, or blood pressure between the groups, suggesting it is generally safe. ^{2 3 5 6 7}

How does the stress task treatment for people with HIV differ from other treatments?

The stress task treatment for people with HIV is unique because it focuses on understanding the relationship between stress, immune function, and pain, rather than directly treating HIV itself. This approach is novel as it aims to explore how stress and pain interact in individuals with HIV, potentially leading to new insights into managing pain and distress in this population. ^{1 2 3 6 7}

Research Team

Rajita Sinha, Ph.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for people living with HIV who may also be dealing with depression, pain, stress, and cannabis use disorder. Participants will be divided into four groups based on their health conditions to take part in two sessions of a task designed to study pain and stress.

Inclusion Criteria

Additional criteria for PLWH: CB positive urine toxicology, meet DSM-5 criteria for CUD and MDD as assessed using SCID-I

Additional criteria for PLWH +CM: HIV-1 test negative, urine toxicology negative, no major medical and psychiatric diagnoses based on DSM-V

Additional criteria for 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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Sessions

Participants undergo 2 sessions of the Yale Pain Stress Task (YPST) to assess stress and pain responses

1 week

2 visits (in-person)

Follow-up

Participants are monitored for drug use and mood symptoms after the experimental sessions

4 weeks

Treatment Details

Interventions

• Yale Pain Stress Task (YPST) (Behavioural Intervention)

Trial Overview The Yale Pain Stress Task (YPST) is being tested to understand its effects on individuals with varying health issues including HIV, depression, and substance use. The study involves two sessions followed by an assessment phase for drug use and mood symptoms.

Participant Groups

Group I: Healthy control (HC) Experimental Treatment 1 Intervention

Participants that are not HIV-positive and no complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)

Group II: HIV-positive and complex morbidity (PLWH/CM+) Experimental Treatment 1 Intervention

Participants that are HIV-positive with complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)

Group III: HIV-positive (PLWH+) Experimental Treatment 1 Intervention

Participants that are HIV-positive only will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)

Group IV: Control and complex morbidity (HC+CM) Experimental Treatment 1 Intervention

Participants that are not HIV-positive and have complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

In a study of 93 persons living with HIV/AIDS, pain-related anxiety was found to significantly correlate with increased symptoms of anxiety and depression, indicating that anxiety about pain can worsen mental health outcomes.

The study suggests that addressing pain-related anxiety may be important for improving the overall well-being of individuals with HIV/AIDS, as it affects their emotional distress beyond other factors like physical health and demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain-related anxiety in relation to anxiety and depression among persons living with HIV/AIDS. Brandt, CP., Zvolensky, MJ., Daumas, SD., et al.[2018]

HIV-positive patients experience significant brain abnormalities in areas related to pain processing, which correlate with higher pain scores, indicating that their pain responses may be abnormal compared to HIV-negative individuals.

Addressing both the physical and affective components of pain in HIV-positive patients could improve their overall quality of life, as lower pain scores are associated with better physical and mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered Associations between Pain Symptoms and Brain Morphometry in the Pain Matrix of HIV-Seropositive Individuals. Castillo, D., Ernst, T., Cunningham, E., et al.[2019]

This study will investigate the relationship between distress, inflammatory reactivity, and pain in 100 people with HIV over 6 months, aiming to understand how distress may exacerbate pain through inflammatory responses.

The research will specifically assess how inflammatory reactivity may mediate the connection between distress and pain, using various validated measures to capture these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: an observational study of distress, immune function and persistent pain in HIV. Madden, VJ., Msolo, N., Mqadi, L., et al.[2023]

Over 60% of the 438 ambulatory AIDS patients surveyed reported frequent or persistent pain, with an average pain intensity of 5.4 out of 10, indicating significant pain levels in this population.

The presence and intensity of pain were linked to more advanced HIV disease and were influenced by demographic factors such as gender and race, highlighting the need for targeted pain management strategies in AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain in ambulatory AIDS patients. I: Pain characteristics and medical correlates. Breitbart, W., McDonald, MV., Rosenfeld, B., et al.[2022]

In a study of 254 adults living with HIV, better central nervous system (CNS) penetration of antiretroviral therapy (measured by the CNS Penetration-Effectiveness score) was not linked to reduced rates of chronic pain, indicating that CNS ARV penetration may not be a key factor in managing pain in these patients.

However, a higher CPE score was found to be an independent risk factor for depression, particularly associated with exposure to the drug zidovudine, suggesting that while pain management may not be directly influenced by ARV CNS penetration, mental health outcomes could be affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better Antiretroviral Central Nervous System Penetration is Not Associated with Reduced Chronic Pain in People Living with Human Immunodeficiency Virus. Robbins, NM., Chaiklang, K., Supparatpinyo, K.[2020]

In a study of 145 HIV-infected individuals with persistent pain, over half (53.8%) were diagnosed with PTSD, highlighting a strong link between trauma and mental health in this population.

Those with PTSD experienced significantly higher pain intensity and greater interference in daily activities, suggesting that addressing PTSD may be crucial for improving pain management and overall quality of life in HIV patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of PTSD on pain experience in persons with HIV/AIDS. Smith, MY., Egert, J., Winkel, G., et al.[2019]

The study found that acute pain, induced by the cold pressor test, affected immune responses and anxiety levels similarly in both HIV+ and HIV- adults, indicating that pain responses may not differ significantly based on HIV status.

Significant associations were observed between perceived pain intensity and various physiological measures, such as heart rate and immune cell counts, suggesting that pain perception can influence both psychological and immune responses in individuals, regardless of their HIV status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a model: effects of pain on immunity in HIV+ and HIV- participants. Eller, LS.[2007]

References

1. England pubmed.ncbi.nlm.nih.gov

Pain-related anxiety in relation to anxiety and depression among persons living with HIV/AIDS. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Altered Associations between Pain Symptoms and Brain Morphometry in the Pain Matrix of HIV-Seropositive Individuals. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Study protocol: an observational study of distress, immune function and persistent pain in HIV. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pain in ambulatory AIDS patients. I: Pain characteristics and medical correlates. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Better Antiretroviral Central Nervous System Penetration is Not Associated with Reduced Chronic Pain in People Living with Human Immunodeficiency Virus. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The impact of PTSD on pain experience in persons with HIV/AIDS. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Testing a model: effects of pain on immunity in HIV+ and HIV- participants. [2007]