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Completed

NCT Number: NCT03036917

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Holbæk Hospital, Holbæk, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cognitive function before opioid reduction

    Time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)

    Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Secondary outcomes

  1. Cognitive function at halfway point

    Time frame: 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 measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  2. Cognitive function at end of reduction

    Time frame: 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)

    Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

  3. Executive function before opioid reduction

    Time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)

    Executive function measured by Trail making test A and B

  4. Executive function at halfway point

    Time frame: 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 measured by Trail making test A and B

  5. Executive function at end of reduction

    Time frame: 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 measured by Trail making test A and B

  6. Morphine use before reduction

    Time frame: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)

    Morphine equivalents before reduction

  7. Morphine use after reduction

    Time frame: 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)

    Morphine equivalents after reduction

  8. Use of other analgesics before reduction

    Time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)

    Use of any other analgesic

  9. Use of other analgesics at halfway point

    Time frame: 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 any other analgesic

  10. Use of other analgesics after reduction

    Time frame: 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 any other analgesic

  11. Quality of life before reduction

    Time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)

    Quality of life measured by SF36

  12. Quality of life at halfway point

    Time frame: 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 measured by SF36

  13. Quality of life at end of reduction

    Time frame: 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 measured by SF36

  14. Risk of anxiety and depression before reduction

    Time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)

    Risk of anxiety and depression measured by Hospital anxiety and depression scale

  15. Risk of anxiety and depression at halfway point

    Time frame: 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 measured by Hospital anxiety and depression scale

  16. Risk of anxiety and depression at end of reduction

    Time frame: 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 measured by Hospital anxiety and depression scale

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Acronym: coffee-cup

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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