Clinical trial NCT03036917: Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain
Official title: Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Nonmalignant Pain
Cognitive Impairment
Opiate Dependence
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pain, treated with opioids and participating in the opioid reduction programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive function before opioid reduction
timeFrame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Secondary outcomes:
measure: Cognitive function at halfway point
timeFrame: 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)
measure: Cognitive function at end of reduction
timeFrame: 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)
measure: Executive function before opioid reduction
timeFrame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
measure: Executive function at halfway point
timeFrame: 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)
measure: Executive function at end of reduction
timeFrame: 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)
measure: Morphine use before reduction
timeFrame: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
measure: Morphine use after reduction
timeFrame: 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)
measure: Use of other analgesics before reduction
timeFrame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
measure: Use of other analgesics at halfway point
timeFrame: 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)
measure: Use of other analgesics after reduction
timeFrame: 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)
measure: Quality of life before reduction
timeFrame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
measure: Quality of life at halfway point
timeFrame: 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)
measure: Quality of life at end of reduction
timeFrame: 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)
measure: Risk of anxiety and depression before reduction
timeFrame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
measure: Risk of anxiety and depression at halfway point
timeFrame: 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)
measure: Risk of anxiety and depression at end of reduction
timeFrame: 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)
Other outcomes:
Locations:
city: Holbæk
country: Denmark
facility: Holbæk Hospital
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Stine Estrup, MD
role: PRINCIPAL_INVESTIGATOR
References: