Chronic Nonmalignant Paincoffee-cupNCT03036917
Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain
An observational study of Chronic Nonmalignant Pain and Cognitive Impairment, run by Zealand University Hospital at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Nonmalignant Pain, Cognitive Impairment, Opiate Dependence
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jan 2018to 3 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients > 18 years of age and able to provide a written consent
- Participating in the opioid reduction programme
Who cannot join
- Not able to speak and understand Danish
- Patients suffering from dementia or psychosis
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Holbæk Hospital
Holbæk, 4300
Zealand University Hospital
Køge, 4600
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Cognitive Dysfunction, Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function before opioid reduction
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Secondary outcomes (16)
Cognitive function at halfway point
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
Morphine use after reduction
Morphine equivalents after reduction
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Jan 2018
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonmalignant PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stine Estrup, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036917
- Sponsor's protocol ID
- SE-4-2016
- Acronym
- coffee-cup
- Status last verified
- Jul 2018
- First submitted
- 10 Jan 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03036917
- Acronym / sponsor ID
- coffee-cup / SE-4-2016
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients > 18 years of age and able to provide a written consent
- Participating in the opioid reduction programme
Key exclusion criteria (2 listed)
- Not able to speak and understand Danish
- Patients suffering from dementia or psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
16 secondary outcomes
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 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 before opioid reduction
Time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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 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)
Morphine use before reduction
Time frame: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
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)
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 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 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)
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 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 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 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 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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Nonmalignant Pain
Recruiting
Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity
Chronic Pain
Active, not recruiting
Effectiveness of Acceptance and Commitment Therapy for Chronic Non-Malignant Pain: A Randomized Controlled Trial
Chronic Non-Malignant Pain (Chronic Musculoskeletal Pain, Chronic Widespread Pain)
Enrolling by invitation
Collaboratory Treatment Pathway for Chronic Pain Patients.
Chronic Pain, Chronic Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stine Estrup, MD principal investigator
Zealand University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Nonmalignant Pain and Cognitive Impairment, run by Zealand University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function before opioid reduction (time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.