RecruitingPhase 2NCT06837857

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

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

Sponsor

Mayo Clinic

Enrollment

200 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Pain, Chronic

Summary

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.

Eligibility

Min Age: 65 Years

Inclusion Criteria4

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 Criteria12

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.

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Interventions

DRUGOpioid

Subjects will receive oral oxycodone as needed for pain which will be titrated weekly based on pain response, adverse effects, and patient preference. Subjects with intolerance to oxycodone will receive the equivalent dosing of morphine as an alternative.

DRUGOpioid Placebo

Subjects will receive a placebo capsule identical to oxycodone, which will similarly be titrated weekly. Subjects with intolerance to the first placebo will receive another placebo capsule identical to morphine.