Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain (I-COAP)

Mayo Clinic

Status and phase: Enrolling; Phase 2

Conditions: Pain, Chronic

Treatments: Drug: Opioid Placebo; Drug: Opioid

Study type: Interventional

Funder types: Other

Identifiers

NCT06837857

24-008096

Details and patient eligibility

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Opioid Group

Experimental group

Description:

The participant will be plugged into an individualized comprehensive tiered pain plan that can include: Tier one (Acetaminophen, NSAIDS, Topicals, TENS unit, Massage, Acupuncture, Physical therapy. Tier two (Cognitive behavioral therapy, joint injections, nerve ablations, peripheral nerve stimulators) and less commonly Tier three (duloxetine, gabapentin). This is modeled after clinical practice. The participants will additionally receive prescription opioids for 6 weeks.

Treatment:

Drug: Opioid

Placebo Group

Placebo Comparator group

Description:

The participant will be plugged into an individualized comprehensive tiered pain plan that can include: Tier one (Acetaminophen, NSAIDS, Topicals, TENS unit, Massage, Acupuncture, Physical therapy. Tier two (Cognitive behavioral therapy, joint injections, nerve ablations, peripheral nerve stimulators) and less commonly Tier three (duloxetine, gabapentin). This is modeled after clinical practice. The participants will additionally receive a prescription opioid placebo for 6 weeks.

Treatment:

Drug: Opioid Placebo