Neuroimaging of Opioid Phase (OPAL)
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.
Conditions:
🦠 Chronic Pain 🦠 Opioid Use
🗓️ Study Start (Actual) 1 June 2023
🗓️ Primary Completion (Estimated) 30 June 2027
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 140
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 June 2023
  • First Submitted that Met QC Criteria 7 June 2023
  • First Posted 15 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified April 2024