Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Opioid

    Drug

    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

    Drug

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Opioid GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

White matter fractional anisotropy (FA) of corpus callosum

Fractional anisotropy of the corpus callosum, adjusted against baseline value.

Time frame
Baseline, 12 months

Secondary outcomes

1

White matter fractional anisotropy (FA) of other axonal tracts

Fractional anisotropy of other white matter structures, adjusted against baseline value.

Time frame
Baseline, 12 months
2

Gray matter cortical thickness

Gray matter cortical thickness from major cortical regions, adjusted baseline values

Time frame
Baseline, 12 months
3

Subcortical gray matter volumes

Subcortical gray matter volumes on MRI, adjusted against baseline values

Time frame
Baseline, 12 months
4

Mayo Preclinical Alzheimer's disease Cognitive Composite (Mayo-PACC) Global-z

This battery of tests includes AVLT (auditory verbal learning test), Animal Fluency, TMTB (trail making test B). Results are reported as a standardized z-score, where a higher z-score indicates better cognitive performance, with the score calculated by summing the z-scores of individual cognitive test components that make up the Mayo-PACC

Time frame
Baseline, 6 weeks, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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