Predictive Markers of the Effects of Opioid Therapy

Study Overview
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Brief Summary
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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

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

Conditions
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Opioid Analgesic Treatment Response, Chronic Pain

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Opioid analgesics<br>Opioid treatment is determined, prescribed, modified and discontinued at the sole discretion of the treating physician at each research site; regardless of generic name, manufacturer, constituent components, route of administration, and dosing schedule (including titration and run-in periods). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores | 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. | After 14-days of opioid treatment | 
| Improvement of health-related quality of life assessed by QLQ-C30 scores | 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. | After 14 days of opioid treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPI worst pain in the past week | Change from baseline | Day 14 post-treatment | 
| BPI least pain in the past week | Change from baseline | Day 14 post-treatment | 
| BPI current pain in the past week | Change from baseline | Day 14 post-treatment | 
| BPI pain severity in the past week | Change from baseline | Day 14 post-treatment | 
| BPI pain interference score | Change from baseline | Day 14 post-treatment | 
| Improvement score | Proportion with score >4 | Day 14 post-treatment | 
| Concomitant and rescue medication |  | Until 14 days post-treatment | 
| Adverse events | Number (%) of the following: Constipation Dry mouth Nausea/Vomiting Sedation Sweats Bad dreams Dysphoria/Delirium Myoclonus/Seizures Pruritus/Urticaria Urinary retention | Until 14 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Opioid analgesics, Prediction study, Pharmaco-EEG