Neuroimaging of Opioid Phase (OPAL)
Purpose
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.
Conditions
- Chronic Pain
- Opioid Use
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Female adults with chronic pain who take prescribed opioid medications |
Opioid taking participants will undergo two study visits, one for each opioid phase ("peak" or "trough") |
|
|
No Intervention Female adults with chronic pain who do not take opioid medications |
Participants with chronic pain who are not taking opioids will undergo one study visit |
|
|
No Intervention Healthy controls |
Healthy female participants who are not taking opioids will undergo one study visit |
|
Recruiting Locations
Durham, North Carolina 27710
More Details
- NCT ID
- NCT05905419
- Status
- Recruiting
- Sponsor
- Duke University
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.