Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain
ConditionPain, Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorMayo Clinic
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Opioid
- Opioid Placebo
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov