Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036917
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

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.


Condition or disease
Chronic Nonmalignant Pain Cognitive Impairment Opiate Dependence

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : May 3, 2019
Actual Study Completion Date : May 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036917


Locations
Layout table for location information
Denmark
Holbæk Hospital
Holbæk, Denmark, 4300
Zealand University Hospital
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Stine Estrup, MD Zealand University Hospital

Layout table for additonal information
Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03036917     History of Changes
Other Study ID Numbers: SE-4-2016
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Cognitive Dysfunction
Opioid-Related Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders