Recruiting
Phase 2

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06837857

Conditions

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Opioid

Opioid Placebo

Study Details

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.

Conditions

Pain, Chronic

Study ID

NCT06837857

Start date

Apr 16, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Opioid Group

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.

placebo comparator: Placebo Group

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.

Interventions

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.

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 measure

  • White matter fractional anisotropy (FA) of corpus callosum [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Tami Werts

507-255-2950Werts.Tamra@mayo.edu

Principal Investigator:

Nafisseh S Warner, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-08.