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RECRUITING
NCT06837857
PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-04-16

Completion Date

2029-12-31

Last Updated

2026-01-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Opioid

Subjects will receive oral oxycodone as needed for pain which will be titrated weekly based on pain response, adverse effects, and patient preference. Subjects with intolerance to oxycodone will receive the equivalent dosing of morphine as an alternative.

DRUG

Opioid Placebo

Subjects will receive a placebo capsule identical to oxycodone, which will similarly be titrated weekly. Subjects with intolerance to the first placebo will receive another placebo capsule identical to morphine.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States