NCT06837857 · Mayo Clinic
Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain
(I-COAP)
What this study is about
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.
View original scientific 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.
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.
Primary outcome measures
White matter fractional anisotropy (FA) of corpus callosum
Time frame: Baseline, 12 months
Fractional anisotropy of the corpus callosum, adjusted against baseline value.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations