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

Last updated: April 23, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Pain

Pain

Treatment

Opioid Placebo

Opioid

Clinical Study ID

NCT06837857
24-008096
  • Ages > 65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Chronic pain of moderate to severe intensity (greater than or equal to 5 /10 averagepain on PEG scale) nearly every day for at least 3 months due to osteoarthritis ofthe knee OR shoulder

  • 65 years of age or older

Exclusion

Exclusion Criteria:

  • Severe mental health disorder (schizophrenia, bipolar disorder, psychosis, historyof 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 RiskToo 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.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Opioid Placebo
Phase: 2
Study Start date:
April 16, 2025
Estimated Completion Date:
December 31, 2031

Study Description

The investigators will recruit 200 adults aged 65 years and older with chronic pain of the knee or shoulder. Each will receive an individualized multimodal pain treatment pathway for 6-weeks - for half of participants this will include a prescription opioid; the other half will receive an identical placebo. After 6 weeks, participants will undergo opioid/placebo taper. The investigators will obtain neuroimaging (MRI), psychometric/cognitive testing, pain scores, and several exploratory patient-reported outcomes at several time-points: before the intervention (all tests), at 6 weeks (all tests except MRI), 6-month phone call (only phone based patient reported outcomes- no MRI), and at 1 year (all tests).

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.