NCT06837857 Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain
| NCT ID | NCT06837857 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Pain, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-04-16 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Nafisseh Warner
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06837857 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Pain, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06837857 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06837857 currently recruiting?
Yes, NCT06837857 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT06837857 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06837857 clinical trial?
NCT06837857 is sponsored by Mayo Clinic. The principal investigator is Nafisseh Warner at Mayo Clinic. The trial plans to enroll 200 participants.