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

NCT03036917 | Completed DMC

• 1 other identifier: SE-4-2016
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Nonmalignant Pain; Cognitive Impairment; Opiate Dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Cognitive function at halfway point

  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

  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

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

• Executive function at halfway point

  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

  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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients \> 18 years of age and able to provide a written consent
• Participating in the opioid reduction programme

You may not qualify if:

• Not able to speak and understand Danish
• Patients suffering from dementia or psychosis

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (2)

Holbæk Hospital

Holbæk, 4300, Denmark

Location

Zealand University Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Stine Estrup, MD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 31, 2017
• Study Start: January 1, 2018
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: July 5, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)