Loading clinical trials...
Loading clinical trials...
Imaging, Cognition, and Opioids in Older Adults With Chronic Pain (I-COAP) Trial
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.
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).
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Start Date
April 16, 2025
Primary Completion Date
July 1, 2029
Completion Date
December 31, 2029
Last Updated
January 8, 2026
200
ESTIMATED participants
Opioid
DRUG
Opioid Placebo
DRUG
Lead Sponsor
Mayo Clinic
NCT06277232
NCT07199361
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05677412