ABILITY: Predictive Markers of the Effects of Opioid Therapy

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT02308306

Collaborator

(none)

Enrollment

Locations

Duration (Months)

12.4

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Opioid Analgesic Treatment Response Chronic Pain

Study Design

Study Type:

Observational

Actual Enrollment :

62 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Opioid analgesics 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).

Outcome Measures

Primary Outcome Measures

Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores [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.
Improvement of health-related quality of life assessed by QLQ-C30 scores [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 Outcome Measures

BPI worst pain in the past week [Day 14 post-treatment]
Change from baseline
BPI least pain in the past week [Day 14 post-treatment]
Change from baseline
BPI current pain in the past week [Day 14 post-treatment]
Change from baseline
BPI pain severity in the past week [Day 14 post-treatment]
Change from baseline
BPI pain interference score [Day 14 post-treatment]
Change from baseline
Improvement score [Day 14 post-treatment]
Proportion with score >4
Concomitant and rescue medication [Until 14 days post-treatment]
Adverse events [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven and the Leuven Centre for Algology & Pain Management	Leuven	Pellenberg	Belgium	3212
2	Department of Rheumatology, Aarhus University Hospital	Aarhus C		Denmark	8000
3	Friklinikken	Give		Denmark	7323
4	Hospitalet Valdemar	Ringsted		Denmark	4100
5	Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care	Ljubljana		Slovenia	1000

Sponsors and Collaborators

University of Aarhus

Investigators

Study Chair: Asbjørn M Drewes, MD, PhD, DMSci, Aalborg University Hospital, Denmark
Study Director: Anne E Olesen, MSc (Pharm), PhD, Aalborg University Hospital, Denmark
Study Director: Kasper Grosen, MHSc, PhD, Aarhus University / Aarhus University Hospital, Denmark
Principal Investigator: Mogens Pfeiffer-Jensen, MD, PhD, Aarhus University Hospital, Denmark
Principal Investigator: Michael Kamp-Jensen, MD, PhD, Hospitalet Valdemar, Denmark
Principal Investigator: Bart Morlion, MD, PhD, University of Leuven / University Hospitals Leuven, Belgium
Principal Investigator: Gorazd Pozlep, MD, Ljubljana University Medical Centre, Slovenia
Principal Investigator: Torsten Jonsson, MD, Hospitalet Valdemar, Denmark