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New treatment option for HIV
Official title Stress and Pain in People Living With HIV
ClinicalTrials.gov ID: NCT06784908
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 68. Healthy volunteers may be eligible.
You may be able to join if
- 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:
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 68 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.