Effects of prescription opioids on brain structure and cognition in older adults with chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between prescription opioid use and brain structural changes in older adults suffering from chronic pain. It will involve 200 participants aged 65 and older, who will receive either opioids or a placebo as part of a multimodal pain treatment pathway over six weeks. Participants will undergo various assessments, including MRI scans and cognitive testing, to evaluate changes in brain structure and function. The study aims to provide insights into the impact of opioids on brain health in this demographic.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Nafisseh Warner — Mayo Clinic

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.