Neuroimaging of Opioid Phase (OPAL)

Not Applicable

Recruiting

• Conditions: Opioid Use; Chronic Pain
• Interventions: Other: Opioid Phase

• Registration Number: NCT05905419
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Female adults with chronic pain who take prescribed opioid medications	Opioid Phase	Opioid taking participants will undergo two study visits, one for each opioid phase ("peak" or "trough")

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States