Cognitive Function and Addiction Under Opioid Tapering

NCT03365817 | Completed Phase 3

• 1 other identifier: H-B-2008-061
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effects of opioid dose reduction in the treatment of chronic pain in adults. Participants were divided in two groups: 1) patients that reduced opioid dose and 2) patients that kept the same opioid dose for six months.

Conditions

Chronic Pain; Opioid Use

Keywords

cognitive function; opioid dependence; opioid withdrawal; quality of life; side effect

Outcome Measures

Primary Outcomes (6)

• Cognitive function - sustained attention

  EKHO, computer program that registers the continuous reaction time to respond to the emission of a sound signal. Scores were summarized in milliseconds using 10th (fastest values), 50th and 90th (slowest values) percentiles. More prolonged times mean worse performance.

  Through study completion up to 4 years.

• Cognitive function - psychomotor speed

  Finger Tapping Test, a mechanical device with a key attached was used to record the number of taps. Score was calculated by the numbers of taps, considering the average of each hand and the differences between hands. Higher scores mean better performance.

  Through study completion up to 4 years.

• Cognitive function - working memory

  Digit Span Test, subjects should repeat orally series of numbers of increasing lengths, in forward and backward orders. Scores were calculated separately for forward and backward exercises, considering the number of correct repetitions. Scores range from 0 to 14. Higher scores mean better performance.

  Through study completion up to 4 years.

• Cognitive function - mental flexibility

  Trail Making Test B, numbers and letters written on a paper should be connected in alternated sequence and increasing order. Score was calculated by the total time spent to correctly conclude the test (seconds). Shorter time mean better performance.

  Through study completion up to 4 years

• Cognitive function - mental state

  Mini Mental State Examination, measures orientation to time and place, registration of words, attention, calculation, and word recall, as well as language and visual construction. Total scores range from 0 to 30; scores below 27 were considered indicative of cognitive dysfunction.

  Through study completion up to 4 years.

• Risk of opioid misuse

  Pain Medication Questionnaire, 26 items responded on a 5-point Likert format scale. Scores range from 0 to 104, higher score means higher risk of opioid misuse. Scores equal or above 22 were considered indicative of risk for opioid addiction.

  Through study completion up to 4 years.

Secondary Outcomes (9)

• Pain intensity

  Through study completion up to 4 years.

• Sleep

  Through study completion up to 4 years.

• Rest

  Through study completion up to 4 years.

• Quality of life

  Through study completion up to 4 years.

• Depression and anxiety

  Through study completion up to 4 years.

Study Arms (2)

Taper off

EXPERIMENTAL

Decrease of opioid daily dose until discontinuation for up to six months.

Drug: Opioids taper off

Control Group

ACTIVE COMPARATOR

No changes on opioids and adjuvant medication for up to six months.

Drug: Opioid stable treatment

Interventions

Opioids taper off DRUG

Decrease of 10% of opioid daily dose every one to two weeks until discontinuation for up to six months.

Also known as: Morphine, oxycodone, metadone, fentanyl, tramadol

Taper off

Opioid stable treatment DRUG

No changes on prescribed opioids and adjuvant medication for the next six months

Control Group

Eligibility Criteria

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

You may qualify if:

• age 18 years old or more
• at least seven years of schooling
• pain duration of at least six months,
• treatment with oral opioids for more than three months
• daily opioid dose ≥ 60 mg of oral morphine equivalent

You may not qualify if:

• not fluent in Danish language
• cancer disease
• poor general health condition
• pregnancy, dementia
• encephalopathy
• brain damage
• cranial base trauma
• enrolled in other studies

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Ministry of Science, Technology and Innovation, Denmark: collaborator
• Hørslev-Fonden: collaborator

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Interventions

Morphine; Oxycodone; Fentanyl; Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Per Sjøgren, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Jette Højsted, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in palliative Medicine

Model Details: Random assignment

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 7, 2017
• Study Start: February 2, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 7, 2017

Record last verified: 2017-12