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Clinical Trials/NCT05905419
NCT05905419
Recruiting
Not Applicable

Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord

Duke University1 site in 1 country140 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Duke University
Enrollment
140
Locations
1
Primary Endpoint
Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 30, 2027
Last Updated
8 months ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy

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.

Secondary Outcomes

  • Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy(During study visits up to 4 weeks apart)

Study Sites (1)

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