Clinical trial NCT06837857: Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain
Official title: Imaging, Cognition, and Opioids in Older Adults With Chronic Pain (I-COAP) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pain, Chronic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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
* 65 years of age or older

Exclusion Criteria:

* Severe mental health disorder (schizophrenia, bipolar disorder, psychosis, history of suicidality, uncontrolled severe depression or anxiety, severe 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 Too l\> 8)
* Residence outside of Minnesota or Wisconsin during opioid intervention period
* Another pain generator that is greater than their knee or shoulder pain
* Anticipated surgery for joint replacement (Knee or shoulder) sooner than 23 months.

Primary outcomes:
measure: White matter fractional anisotropy (FA) of corpus callosum
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: White matter fractional anisotropy (FA) of other axonal tracts
timeFrame: Baseline, 12 months
measure: Gray matter cortical thickness
timeFrame: Baseline, 12 months
measure: Subcortical gray matter volumes
timeFrame: Baseline, 12 months
measure: Mayo Preclinical Alzheimer's disease Cognitive Composite (Mayo-PACC) Global-z
timeFrame: Baseline, 6 weeks, 12 months
measure: Trailmaking Test A
timeFrame: Baseline, 6 weeks, 12 months
measure: Digit span memory test
timeFrame: Baseline, 6 weeks, 12 months
measure: Mayo Test Drive
timeFrame: Baseline, 6 weeks, 6 month web based, 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nafisseh Warner
role: PRINCIPAL_INVESTIGATOR
References: