NCT05905419 · Duke University
Neuroimaging of Opioid Phase (OPAL)
(OPAL)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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
Primary outcome measures
Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy
Time frame: During study visits up to 4 weeks apart
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations