Duke University Medical Center
Durham, North Carolina, 27710, United States
Location status: Recruiting
NCT Number: NCT05905419
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Healthy Controls:
Inclusion criteria
for Individuals with Chronic Pain:
Exclusion criteria
(for both groups):
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
Time frame: 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.
Time frame: During study visits up to 4 weeks apart
Compare spinal cord fMRI-based response and resting-state functional connectivity.
Contact information is provided by the study sponsor or research team.
Angelina Xiong, BS
CONTACT
HAPN Lab Manager
CONTACT
Duke University
Other
Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord
Acronym: OPAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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