Chronic Pain, Opioid Use
Conditions
Keywords
fibromyalgia, women, brain, functional MRI, opioid, opiate, narcotic, chronic pain, pain
Brief summary
The purpose of this study is to compare activity in the brains of female adults with chronic pain and/or opioid use, and healthy female adults that may help to develop new and targeted treatments for adults with chronic pain and alternatives to opioid therapy.
Detailed description
The objective of the study is to determine differences in neurophysiology and behavior during different phases of opioid use in patients. Study activities will include neuroimaging (MRI and fMRI), behavioral tasks, sensory testing, blood draws, and questionnaires. The neuroimaging data will be analyzed using specialized software; data from questionnaires, sensory testing, and behavioral task performance will be analyzed using standard statistical software. Risks and safety concerns include standard, minimal risks associated with MRI scans, sensory testing, blood draws, and confidentiality.
Interventions
OTHEROpioid Phase
Opioid-taking patients are assigned to take their prescribed opioid medication before ("peak" opioid phase) during 1 scan and after ("trough" opioid phase) during the other MRI scan
Sponsors
Duke University
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Healthy Controls: 1. female and ages 18+ 2. ability to read/understand English and give consent to participate 3. no current or history of chronic pain 4. not regularly taking any pain-relieving or mood-altering medications (per PI discretion) 5. absence of use of opioid medications Inclusion Criteria for Individuals with Chronic Pain: 1. female and ages 18 + 2. ability to read/understand English and give consent to participate 3. self-reported or physician diagnosis of fibromyalgia and/or chronic pain 4. current use of opioid medication(s) for inclusion in the opioid patient group -OR- absence of use of opioid medications for inclusion in the non-opioid patient group
Exclusion criteria
(for both groups): 1. limited ability to participate fully in behavioral tasks, longitudinal follow-up 2. MRI contraindication 3. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study 4. male
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy | During study visits up to 4 weeks apart | Compare brain fMRI-based response to reward stimuli during a monetary incentive delay (MID) task and functional connectivity of brain reward circuitry during resting state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy | During study visits up to 4 weeks apart | Compare spinal cord fMRI-based response and resting-state functional connectivity. |
Countries
United States
Contacts
CONTACTHAPN Lab Manager
CONTACTAngelina Xiong, BS
PRINCIPAL_INVESTIGATORKatherine T Martucci, PhD
Duke University
Outcome results
None listed