Actively Recruiting

Phase 2
Age: 65Years +
All Genders
NCT06837857

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

Led by Mayo Clinic · Updated on 2026-01-08

200

Participants Needed

1

Research Sites

245 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 65 years of age or older
  • Chronic pain lasting longer than 3 months
  • Moderate to severe pain nearly every day (average PEG score >5)
  • Persistent pain despite use of more than one analgesic (e.g., Tylenol, Ibuprofen, lidocaine patch)
Not Eligible

You will not qualify if you...

  • Untreated severe or uncontrolled mental health conditions (schizophrenia, bipolar disorder, psychosis, history of suicidality, depression, anxiety, PTSD)
  • Severe liver disease (cirrhosis) or kidney disease (end-stage renal disease on dialysis or GFR < 30)
  • Cognitive impairment (Kokmen Short Test score < 29)
  • Life expectancy less than 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 score ≥ 8)
  • Residence outside Minnesota or Wisconsin during opioid intervention period
  • Another pain source greater than their knee, shoulder, or low back pain
  • Anticipated knee or shoulder joint replacement surgery within 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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