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

Description

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

Pain, Chronic

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Pain, Chronic
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Nafisseh Warner, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2031-12-31