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Completed

NCT Number: NCT02308306

Predictive Markers of the Effects of Opioid Therapy

The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by developing an implementable clinical computerised decision support system based on individual patient characteristics.

The investigators hypothesize that successful pain control with opioids can be predicted before treatment initiation with advanced data analyses of data originating from pre-treatment EEG, QST and pain-related catastrophic thinking.

The primary objective of this study is the identification of markers that can be used to individualize treatment recommendations, i.e. to reliably predict the response of pain to opioids.

Markers are selected among the most promising data and machine-learning methods are used for the prediction. This includes determining the associations between a battery of selected pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in opioid naïve chronic pain patients, including indication and responder identification.

The key secondary objectives are as follows: to investigate pre-treatment clinical predictive markers as predictors of opioid treatment efficacy and effectiveness in terms of the following:

* Pain intensity and unpleasantness * Use of rescue analgesics * Physical functioning * Global improvement and satisfaction with treatment

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Key information

Conditions

Opioid Analgesic Treatment Response Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KU Leuven and the Leuven Centre for Algology & Pain Management, Leuven, Pellenberg, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pain duration ≥ 3 months.
  • Minimum baseline pain intensity ≥ 4 on a 0-10 numerical rating scale (over the past week).
  • Maximum baseline pain intensity < 9 on a 0-10 numerical rating scale (over the past week).
  • Prescribed opioid treatment (ATC: N02)
  • Anticipated to stay on prescribed opioid treatment throughout the study, i.e. >14 days.
  • Anticipated to stay on any concomitant non-opioid treatment throughout the study, i.e. >14 days.
  • Subject may be male or female, age >18 years old.
  • Is willing and able to comply with study procedures as judged by the site investigator.
  • Subject has voluntarily signed and dated the study-specific informed consent form, approved by an Independent Ethics Committee, after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent form must be signed before any study-specific procedures are performed.

Exclusion criteria

  • Has a mental incapacity or language barriers precluding adequate understanding of study procedures.
  • Is considered by the site investigator unsuitable to participate in the study for any other reason, for instance due to a significant serious underlying condition.
  • Recently received opioids on a daily basis (within the last 10 weeks).
  • Current alcohol or substance abuse, according to the site investigator's medical judgement.
  • Is anticipated to undergo a painful procedure(s) (e.g. surgery) during the study, which can interfere with the experience of the chronic pain condition for which the subject is to receive opioids.

Treatment and study plan

Primary outcomes

  1. Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores

    Time frame: After 14-days of opioid treatment

    The absolute and percentage change from baseline in ratings of average pain in the past week at Day 14. Of note, a percentage change of ≥30% is considered clinically significant.

  2. Improvement of health-related quality of life assessed by QLQ-C30 scores

    Time frame: After 14 days of opioid treatment

    The absolute and percentage change from baseline in ratings of health-related quality of life in the past week at Day 14. A subjectively significant change in QLQ-C30 scores is one that is ≥10 from baseline.

Secondary outcomes

  1. BPI worst pain in the past week

    Time frame: Day 14 post-treatment

    Change from baseline

  2. BPI least pain in the past week

    Time frame: Day 14 post-treatment

    Change from baseline

  3. BPI current pain in the past week

    Time frame: Day 14 post-treatment

    Change from baseline

  4. BPI pain severity in the past week

    Time frame: Day 14 post-treatment

    Change from baseline

  5. BPI pain interference score

    Time frame: Day 14 post-treatment

    Change from baseline

  6. Improvement score

    Time frame: Day 14 post-treatment

    Proportion with score >4

  7. Concomitant and rescue medication

    Time frame: Until 14 days post-treatment

  8. Adverse events

    Time frame: Until 14 days post-treatment

    Number (%) of the following:

    • Constipation
    • Dry mouth
    • Nausea/Vomiting
    • Sedation
    • Sweats
    • Bad dreams
    • Dysphoria/Delirium
    • Myoclonus/Seizures
    • Pruritus/Urticaria
    • Urinary retention

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Predictive Markers of the Effects of Opioid Therapy in Opioid naïve Patients With Chronic Pain: an International, Multi-centre, Observational Cohort Study (ABILITY)

Acronym: ABILITY

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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