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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Opiate Dependence; Chronic Nonmalignant Pain

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Denmark
  • Holbæk, Denmark, 4300
    • Holbæk Hospital
  • Køge, Denmark, 4600
    • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Stine Estrup, MD, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 3, 2019
• Study Completion (Actual): May 3, 2019

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Chronic Pain; Opioid-Related Disorders
• Other Study ID Numbers: SE-4-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No