RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-16
Study Completion:2031-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06837857

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.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 65 years of age or older
  1. * Severe mental health disorder (schizophrenia, bipolar disorder, psychosis, history of suicidality, uncontrolled severe depression or anxiety, severe PTSD)
  2. * Severe liver (cirrhosis) or kidney disease (ESRD on dialysis or GFR\< 30)
  3. * Cognitive impairment (Kokmen Short Test of Mental Status score \< 29)
  4. * Life expectancy \< 12 months
  5. * Contraindications to MRI
  6. * Non-English speaking
  7. * Opioid use within the past 6 months
  8. * Contraindications or previous intolerance to prescription opioids
  9. * Substance use disorder or high-risk for opioid-related adverse effects (Opioid Risk Too l\> 8)
  10. * Residence outside of Minnesota or Wisconsin during opioid intervention period
  11. * Another pain generator that is greater than their knee or shoulder pain
  12. * Anticipated surgery for joint replacement (Knee or shoulder) sooner than 23 months.

Contacts and Locations

Principal Investigator

Nafisseh Warner
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Nafisseh Warner, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-16
Study Completion Date2031-12-31

Study Record Updates

Study Start Date2025-04-16
Study Completion Date2031-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pain, Chronic