Chronic Widespread Pain
Conditions
Brief summary
To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV
Detailed description
The prevalence of chronic widespread pain (CWP) in individuals infected with the human immunodeficiency virus (HIV-1) includes regional and widespread musculoskeletal pain of neuropathic and inflammatory nature. HIV-related CWP leads to 10x greater odds of functional impairment. However, the specific mechanisms that contribute to CWP in HIV are not understood. Thus, pharmacological and non-pharmacological approaches to mitigate CWP have had minimal benefits, contributing to an overreliance on opioids and alarming rise in addiction and overdose. The overall objective of this study is to address the gap in the knowledge of the pathogenesis of HIV-related CWP. Specifically, the role of impaired endogenous opioid synthesis/release from leukocytes in people with HIV (PWH) who self-report CWP will be explored. Leukocytes (neutrophils, monocytes/macrophages, and lymphocytes) are a rich source of opioid peptides (Met-enkephalin, dynorphin A, β-endorphin) that inhibit nociception by binding to peripheral opioid receptors. Therefore, to establish whether decreased peripheral opioid peptides correlate with experimental pain measures in PWH with self-reported CWP, quantitative sensory testing (QST) will be completed before and after administration of methylnaltrexone bromide (RELISTOR), a clinically available, peripherally acting opioid receptor antagonist.
Interventions
Relistor is a peripherally acting opioid receptor antagonist approved by the FDA for relief of opioid-induced constipation
Sponsors
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Confirmed HIV diagnosis and currently a patient in the UAB 1917 HIV Clinic * Age 19 - 65; the lower end of this age range was chosen to capture young adults with HIV infection, and participants over 65 years are increasingly likely to meet one or more
Exclusion criteria
* All people living with HIV must be currently receiving stable antiretroviral therapy (ART) for inclusion in this study * Non-HIV participants must be confirmed as HIV negative. HIV-negative participants with chronic widespread pain must self-report bodily pain more than once per week for at least three consecutive months and HIV-negative participants without chronic pain must self-report no pain, or pain less frequently than once per week for at least three consecutive months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative sensory testing (QST) | At baseline (study visit 1) | Measured at baseline and 30 min post intervention to assess change in response. (0=no pain, 100=most pain) * Heat Pain - 1) A slowly increasing heat stimulus (44°C, 46°C, and 48°C) will be delivered; 2) a series of 5 heat pulses (about 2 sec) will be given and pain will be rated (0-100) * Touch Test Pain. Von Frey filament will be tapped on knee and hand and asked to rate the pain (0-100) after a single tap, and after 10 consecutive taps * Pressure Pain Threshold. A slowly increasing pressure will be applied on forearm and shoulder with a probe (Algomed) till pain is felt. Then constant pressure will be applied till the sensation first becomes painful to assess threshold in kilopascals * Combined Pressure and Cold Pain. Hand will be immersed in cold water (10°C). After 30 sec, pain intensity will be rated (0-100). Hand will be kept in cold water for another 30 sec and then the pressure pain test will be performed, and first instance of pain due to pressure will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| McGill Pain Questionnaire-Short Form | At baseline (study visit 1) | 15 descriptors (11 sensory; 4 affective) using an intensity scaled ranging from 0-3 on pain scale (0 = no pain, 1 = mild pain, 2 = moderate pain or 3 = severe pain) |
| Measuring endogenous opioid peptides in plasma and peripheral leukocytes | At baseline (study visit 1) | 20 ml blood will be drawn to isolate plasma and peripheral leukocytes |
Countries
United States
Contacts
Primary ContactSaurabh Aggarwal, MD., PhD
Outcome results
None listed