Stress and Pain in People Living With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-68
SponsorYale University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Yale Pain Stress Task (YPST)
Other interventionIndividuals in the experimental cohort will be scheduled for 2 experimental sessions 1-3 days apart. The YPST stress experiment includes a stress and no-stress session (order randomly assigned, counter-balanced across subjects), and involves multiple (up to 3) unpredictable number of consecutive 3-minute trials of ice-bath (stress) or warm-bath (no stress) forearm immersion (stress) with subjective, physiologic endocrine and immune assessments repeated at specified time points.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: HIV-positive (PLWH+)Experimental treatment 1 intervention
Group B: HIV-positive and complex morbidity (PLWH/CM+)Experimental treatment 1 intervention
Group C: Healthy control (HC)Experimental treatment 1 intervention
Group D: Control and complex morbidity (HC+CM)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in cortisol levels
Mean change in cortisol levels (pg/ml) assessed using repeated blood sampling over 2 hour period on 2 separate days to extract plasma for cortisol measurement using standard RIA assay procedures.
Time frame
day 1 and day 32
Change in adrenocorticotropic hormone (ACTH) levels
Mean change in pain stress assessed using repeated blood sampling over 2 hour period on 2 separate days to extract plasma for ACTH measurement using standard RIA assay procedures.
Time frame
day 1 and day 33
Change in pain stress
Mean change in pain stress assessed using repeated sampling over 2 hour period on 2 separate days using 10-point visual analog scales (VAS) where 0 is not at all and 10 is the most pain being experienced.
Time frame
day 1 and day 3Secondary outcomes
1
Mean behavioral pain tolerance
Time in seconds that hand remains immersed in ice cold and warm water over 3 trials of 3 minutes each as a measure of behavioral pain tolerance
Time frame
day 1 or day 32
Mean Heart Rate
Heart rate (bpm) assessed using repeated sampling over 2 hour period on 2 separate days using standard heart rate monitor.
Time frame
day 1 and day 33
Mean Blood pressure (systolic and diastolic)
Blood pressure (mmHg), systolic and diastolic,assessed using repeated sampling over 2 hour period on 2 separate days using standard blood pressure monitor.
Time frame
day 1 and day 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov