Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA055850 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female adults with chronic pain who take prescribed opioid medications | Experimental | Opioid taking participants will undergo two study visits, one for each opioid phase ("peak" or "trough") |
|
| Female adults with chronic pain who do not take opioid medications | No Intervention | Participants with chronic pain who are not taking opioids will undergo one study visit | |
| Healthy controls | No Intervention | Healthy female participants who are not taking opioids will undergo one study visit |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Phase | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy | 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. | During study visits up to 4 weeks apart |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy | Compare spinal cord fMRI-based response and resting-state functional connectivity. | During study visits up to 4 weeks apart |
Not provided
Inclusion Criteria for Healthy Controls:
Inclusion Criteria for Individuals with Chronic Pain:
Exclusion Criteria (for both groups):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HAPN Lab Manager | Contact | 919-684-2758 | chronicpainresearch@duke.edu | |
| Angelina Xiong, BS | Contact | 919-684-3136 | angelina.xiong@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katherine T Martucci, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
Not provided
| Label | URL |
|---|---|
| Human Affect \& Pain Laboratory (Duke Chronic Pain Lab) | View source |
| Please complete this survey as a first step to join the study. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |