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Recruiting NCT06837857

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

Phase II Interventional Pain, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Opioid, Opioid Placebo.
Who it may be relevant to
Registry conditions: Pain, Chronic. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

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).

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]
Secondary outcome measures (7)
  • White matter fractional anisotropy (FA) of other axonal tracts [Time frame: Baseline, 12 months]
  • Gray matter cortical thickness [Time frame: Baseline, 12 months]
  • Subcortical gray matter volumes [Time frame: Baseline, 12 months]
  • Mayo Preclinical Alzheimer's disease Cognitive Composite (Mayo-PACC) Global-z [Time frame: Baseline, 6 weeks, 12 months]
  • Trailmaking Test A [Time frame: Baseline, 6 weeks, 12 months]
  • Digit span memory test [Time frame: Baseline, 6 weeks, 12 months]
  • Mayo Test Drive [Time frame: Baseline, 6 weeks, 6 month web based, 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06837857 · 24-008096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗