Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain
RecruitingPhase 2NCT06837857
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to determine whether exposure to prescription opioids is associated with brain structural changes on magnetic resonance imaging (MRI), with the primary outcome of white matter integrity as measured by fractional anisotropy of the corpus callosum.
Study details
- Official title
- Imaging, Cognition, and Opioids in Older Adults With Chronic Pain (I-COAP) Trial
- Conditions
- Interventions
- Drug: Opioid
- Drug: Opioid Placebo
- Sponsor
- Mayo Clinic
- Start date
- 2025-04-16
- Primary completion
- 2029-07-01
- Sex
- All
- Age range
- from 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06837857