Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2023-06-01
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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")
Opioid Phase
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
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 interventions assigned to this group
Healthy controls
Healthy female participants who are not taking opioids will undergo one study visit
No interventions assigned to this group
Interventions
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Opioid Phase
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
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Katherine T Martucci, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Human Affect \& Pain Laboratory (Duke Chronic Pain Lab)
Please complete this survey as a first step to join the study.
Other Identifiers
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Pro00110253
Identifier Type: -
Identifier Source: org_study_id
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