Neuroimaging of Opioid Phase

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neuroimaging of Opioid Phase

Conditions
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Chronic Pain, Opioid Use

Intervention / Treatment
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* Other: 2 Study Visits with MRI Scanning
* Other: 1 Study Visit with MRI Scanning
* Drug: Opioid Randomization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Healthy Controls: female and ages 18+ ability to read/understand English and give consent to participate no current or history of chronic pain not regularly taking any pain-relieving or mood-altering medications (per PI discretion) absence of use of opioid medications Inclusion Criteria for Individuals with Chronic Pain: female and ages 18 + ability to read/understand English and give consent to participate self-reported or physician diagnosis of fibromyalgia and/or chronic pain 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): limited ability to participate fully in behavioral tasks, longitudinal follow-up MRI contraindication any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study male

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female adults with chronic pain who take prescribed opioid medications<br>Opioid taking participants will undergo two study visits, one for each opioid phase (peak or trough) | Other: 2 Study Visits with MRI Scanning<br>* Participant undergoes MRI scanning, blood draw(s), urine sample(s)<br>Drug: Opioid Randomization<br>* Participant is randomized to take their prescribed opioid medication before (peak opioid phase) or after (trough opioid phase) the MRI scan<br>|
| Female adults with chronic pain who do not take opioid medications<br>Participants with chronic pain who are not taking opioids will undergo one study visit | Other: 1 Study Visit with MRI Scanning<br>* Participant undergoes MRI scanning, blood draw, urine sample<br>|
| Healthy controls<br>Healthy female participants who are not taking opioids will undergo one study visit | Other: 1 Study Visit with MRI Scanning<br>* Participant undergoes MRI scanning, blood draw, urine sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain, fibromyalgia, women, functional MRI, opioid, opiate, narcotic, chronic pain, pain