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Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain

RecruitingPhase 2

Imaging, Cognition, and Opioids in Older Adults With Chronic Pain (I-COAP) Trial

Who can join

Ages 65 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Mayo Clinic · Participants: 200 · Started: Apr 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06837857

Locations in the U.S.

MinnesotaMayo Clinic in Rochester, Rochester

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.