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

Cognitive Impairment Clinical Trial

— coffee-cup  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036917
• Other study ID #: SE-4-2016
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: May 3, 2019

Study information

• Verified date: July 2018
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Nonmalignant Pain
• Chronic Pain
• Cognitive Dysfunction
• Cognitive Impairment
• Opiate Dependence
• Opioid-Related Disorders

Locations

Country	Name	City	State
Denmark	Holbæk Hospital	Holbæk
Denmark	Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Morphine use before reduction	Morphine equivalents before reduction	At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)