Phase
Condition
Chronic Pain
Fibromyalgia
Pain
Treatment
Relistor Injectable Product
Clinical Study ID
Ages 19-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 withHIV infection, and participants over 65 years are increasingly likely to meet one ormore 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 participantswith chronic widespread pain must self-report bodily pain more than once per weekfor at least three consecutive months and HIV-negative participants without chronicpain must self-report no pain, or pain less frequently than once per week for atleast three consecutive months
Exclusion
Exclusion Criteria:
Anemia
Current or past history of blood disorders which may increase hemolysis
Active microbial infections which may alter the quantity or quality of bloodinflammatory cells such as monocytes and neutrophils
Use of certain medication other than antiretroviral therapy that might conflict withstudy observations. However, participants will not be excluded or asked to withdrawfrom medications used for pain management since temporary withdrawal from thesemedications could affect pain measures (exceptions will be therapies such asmethadone or buprenorphine used to treat opioid addiction). Only those who arestable on these medications for at least 60 days will be included. All patientmedications used for at least the 60 days prior to participation will be recordedand controlled in statistical analyses as needed
Systemic rheumatic disease (e.g., rheumatoid arthritis, systemic lupuserythematosus). These rheumatologic conditions will be excluded due to theirautoimmune characteristic. . Cachexia (wasting syndrome) and severe frailty. Thisexclusion is in place to protect against the stress of experimental pain testing
A history of clinically significant surgery in the past year
Uncontrolled hypertension (i.e. SBP/DBP of >150/95) or cardiovascular or peripheralarterial disease. These exclusions are in place primarily for safety reasons becausethe cold pressor task represents a cardiovascular challenge. However, uncontrolledhypertension can also affect pain perception, which is another reason for excludingthese individuals
Poorly controlled diabetes (HbA1c > 8%) for both safety reasons, and becausediabetic neuropathy could alter pain perception
Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy)
Serious psychiatric disorder requiring hospitalization within the past 12 months orcharacterized by active suicidal ideation
Any participant deemed to be actively suicidal upon study screening will be escortedto the UAB emergency room and evaluated by the Psychiatry Service
Diminished cognitive function that would interfere with understanding of studyprocedures. The Realm Health Literacy Test will be administered to ensure thatparticipants are free of cognitive impairment that would compromise studyparticipation
Pregnancy. Inclusion/exclusion criteria will be verified using the screening tool incombination with review of participants' medical records
Study Design
Study Description
Connect with a study center
Clinical Research Unit at the University of Alabama at Birmingham
Birmingham, Alabama 35205
United StatesSite Not Available
Ambulatory Care Center, Florida International University
Miami, Florida 33199
United StatesActive - Recruiting
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