Neuroimaging of Opioid Phase (OPAL)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05905419
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

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 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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
HAPN Lab Manager
919-684-2758

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