Prescription Opioids, Brain Structure, And Cognition In Older Adults With Chronic Pain

Overview

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Chronic pain of moderate to severe intensity (greater than or equal to 5 /10 average pain on PEG scale) nearly every day for at least 3 months due to osteoarthritis of the knee OR shoulder
* 65 years of age or older

Exclusion Criteria:

* Severe mental health disorder (schizophrenia, bipolar disorder, psychosis, history of suicidality, uncontrolled severe depression or anxiety, severe 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 Too l\> 8)
* Residence outside of Minnesota or Wisconsin during opioid intervention period
* Another pain generator that is greater than their knee or shoulder pain
* Anticipated surgery for joint replacement (Knee or shoulder) sooner than 23 months.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/18/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nafisseh Warner, M.D.

Open for enrollment

Contact information:

Nafisseh Warner M.D.

(507) 266-9670

Warner.Nafisseh@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20581639

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