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New treatment option for Pain, Chronic
Official title Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain
ClinicalTrials.gov ID: NCT06837857
What this study is testing
What is Opioid?
Opioid is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for pain, chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.