Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain

Study Overview
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Brief Summary
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This study aims to investigate the cognitive function of patients in the opioid reduction programme at the multidisciplinary pain centre at Zealand University Hospital Køge. The patients will be tested before, halfway through, and after the programme.

Detailed Description
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The number of patients with chronic non-malignant pain is high and constant. An estimated 3-5% of the population use opioids daily. These patients have a lower quality of life and a higher use of healthcare services. This leads to enormous costs, both human and economic. Many patients lose their ability to work, not only because of the pain, but also because of their treatment. For a long period, opioids have been prescribed for chronic pain, even though the evidence is scarce. A rising conscience about opioid use is on the way, and now, there is a tendency to reduce, rather than increase opioids. The reasons are many: Constipation, inability to drive, a sense of drowsiness and no relief of pain, just to name a few. Furthermore, opioids may have decreased effect over time or may even lead to higher levels of pain. Many patients are at first reluctant to start the reduction programme. Mostly because the patients may not be aware of the effects, the drugs are having on them. Many patients value their opioid treatment as positive and necessary, in spite of the many adverse effects. The investigators wanted to test the cognitive function of patients before, during and after opioid reduction. The results can be used to help patients understand the deleterious effects of high opioid usage, and can also be used to motivate the individual patient along the way.

Official Title
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Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study

Conditions
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Chronic Nonmalignant Pain, Cognitive Impairment, Opiate Dependence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years of age and able to provide a written consent Participating in the opioid reduction programme Exclusion Criteria: Not able to speak and understand Danish Patients suffering from dementia or psychosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function before opioid reduction | Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function at halfway point | Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | 
| Cognitive function at end of reduction | Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). | When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | 
| Executive function before opioid reduction | Executive function measured by Trail making test A and B | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | 
| Executive function at halfway point | Executive function measured by Trail making test A and B | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | 
| Executive function at end of reduction | Executive function measured by Trail making test A and B | When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | 
| Morphine use before reduction | Morphine equivalents before reduction | At first visit to pain clinic (Individual date, inclusion is possible throughout study period) | 
| Morphine use after reduction | Morphine equivalents after reduction | At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | 
| Use of other analgesics before reduction | Use of any other analgesic | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | 
| Use of other analgesics at halfway point | Use of any other analgesic | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | 
| Use of other analgesics after reduction | Use of any other analgesic | At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | 
| Quality of life before reduction | Quality of life measured by SF36 | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | 
| Quality of life at halfway point | Quality of life measured by SF36 | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | 
| Quality of life at end of reduction | Quality of life measured by SF36 | At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | 
| Risk of anxiety and depression before reduction | Risk of anxiety and depression measured by Hospital anxiety and depression scale | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | 
| Risk of anxiety and depression at halfway point | Risk of anxiety and depression measured by Hospital anxiety and depression scale | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | 
| Risk of anxiety and depression at end of reduction | Risk of anxiety and depression measured by Hospital anxiety and depression scale | At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) |