Effects of prescription opioids on brain structure and cognition in older adults with chronic pain
Imaging, Cognition, and Opioids in Older Adults With Chronic Pain (I-COAP) Trial
This study is testing how taking prescription opioids affects the brain and thinking skills in older adults with chronic pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06837857 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between prescription opioid use and brain structural changes in older adults suffering from chronic pain. It will involve 200 participants aged 65 and older, who will receive either opioids or a placebo as part of a multimodal pain treatment pathway over six weeks. Participants will undergo various assessments, including MRI scans and cognitive testing, to evaluate changes in brain structure and function. The study aims to provide insights into the impact of opioids on brain health in this demographic.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older with chronic knee or shoulder pain of moderate to severe intensity.
Not a fit: Patients with severe mental health disorders, significant cognitive impairment, or contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help clarify the effects of prescription opioids on brain health, potentially guiding safer pain management strategies for older adults.
How similar studies have performed: While there have been studies on opioid effects, this specific investigation into brain structure and cognition in older adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 65 years of age or older * Pain for longer than 3 months (chronic) * Moderate to severe pain nearly every day (averaged PEG score \>5) * Persistent pain despite use of \>1 analgesic (Tylenol, Ibuprofen, lidocaine patch, etc) Exclusion Criteria: * Untreated severe/uncontrolled Mental health (schizophrenia, bipolar disorder, psychosis, history of suicidality, depression or anxiety, PTSD) * Severe liver (cirrhosis) or kidney disease (ESRD on dialysis or GFR\< 30) * Cognitive impairment (Kokmen Short Test of Mental Status score \< 29) * Life expectancy \< 12 months * Contraindications to MRI * Non-English speaking * Opioid use within the past 6 months * Contraindications or previous intolerance to prescription opioids * Substance use disorder or high-risk for opioid-related adverse effects (Opioid Risk Tool ≥ 8) * Residence outside of Minnesota or Wisconsin during opioid intervention period * Another pain generator that is greater than their knee or shoulder or low back pain * Anticipated surgery for joint replacement (Knee or shoulder) sooner than 3 months.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Nafisseh Warner — Mayo Clinic
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.