Comparing brain activity in women with chronic pain and opioid use to healthy women
Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord
This study looks at how brain activity differs between women with chronic pain and opioid use and healthy women to help find better treatments for pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05905419 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the differences in brain activity between female adults suffering from chronic pain and/or using opioids and healthy female adults. It employs neuroimaging techniques such as MRI and fMRI, alongside behavioral tasks, sensory testing, blood draws, and questionnaires to gather comprehensive data. The goal is to identify neurophysiological and behavioral variations that could inform the development of targeted treatments for chronic pain and alternatives to opioid therapy. The data will be analyzed using specialized software for neuroimaging and standard statistical methods for other assessments.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with chronic pain conditions like fibromyalgia or those currently using opioids.
Not a fit: Patients who are male or do not have chronic pain or opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new, targeted treatments for chronic pain that reduce reliance on opioids.
How similar studies have performed: Other studies have shown promise in using neuroimaging to understand chronic pain, but this specific approach focusing on opioid phases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Katherine T Martucci, PhD — Duke University
- Study coordinator: HAPN Lab Manager
- Email: chronicpainresearch@duke.edu
- Phone: 919-684-2758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.