Neuroimaging of Opioid Phase (OPAL)
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT05905419
- Status
- Recruiting
Conditions
- Chronic Pain
- Opioid Use
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Opioid Phase — OTHEROpioid-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
Study Details
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.
Key Dates
- Start date
- Jun 1, 2023
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Female adults with chronic pain who take prescribed opioid medicationsOpioid 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 medicationsParticipants with chronic pain who are not taking opioids will undergo one study visit
- No Intervention: Healthy controlsHealthy female participants who are not taking opioids will undergo one study visit
Primary Outcome Measure
Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy [ Time Frame: During study visits up to 4 weeks apart ]
Central Contacts
- HAPN Lab Manager919-684-2758
- Angelina Xiong, BS919-684-3136
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 |
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