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Search / Trial NCT05905419

Neuroimaging of Opioid Phase (OPAL)

Launched by DUKE UNIVERSITY · Jun 7, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Fibromyalgia Women Brain Functional Mri Opioid Opiate Narcotic Chronic Pain Pain

ClinConnect Summary

The OPAL study is looking to learn more about how the brains of women with chronic pain, particularly those who use opioids, compare to the brains of healthy women. By doing this, researchers hope to find better treatments for chronic pain and explore alternatives to opioid medications. They are currently recruiting female participants aged 18 and older, either those who have chronic pain (like fibromyalgia) and may be using opioids or those who are healthy and do not have any history of chronic pain or opioid use.

If you choose to participate, you'll undergo some brain scans and other assessments to help researchers gather information. It's important to note that participants should be able to understand and provide consent in English and must meet specific health criteria. For example, healthy participants should not be taking pain medications or have chronic pain, while those with chronic pain can be either using opioids or not. Overall, this study aims to improve our understanding of chronic pain and find new ways to help people suffering from it.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria for Healthy Controls:
  • 1. female and ages 18+
  • 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
  • Inclusion Criteria for Individuals with Chronic Pain:
  • 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 (for both groups):
  • 1. limited ability to participate fully in behavioral tasks, longitudinal follow-up
  • 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

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Katherine T Martucci, PhD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported