QSPainRelief-STRAT (QSPR-STRAT)

QSPainRelief-STRAT: A Questionnaire-based Evaluation of Perceived Clinical Outcome in Patients With Persistent Pain Receiving an Opioid and Non-opioid Treatment Combination, Stratified According to Age and Sex

Investigating the clinical outcomes of drug combinations (opioid + medication acting on the central nervous system) in patients suffering from persistent pain (pain lasting for at least three months) through patient-reported outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Analgesia; Adverse Drug Event; Drug Interaction
• Intervention / Treatment: Combination product: Opioid drug + CNS-acting add-on drug

Detailed Description

This study is part of the QSPainRelief project funded by the European Union's Horizon 2020 research and innovation program (grant agreement 848068; http://qspainrelief.eu).

The QSPainRelief project aims to setup, calibrate and validate a platform to predict the effects of treatment combinations according to patient characteristics such as age and sex (QSPainRelief platform) which integrates recently developed (1) physiologically based pharmacokinetic models to quantitate and adequately predict drug pharmacokinetics in human CNS, (2) target-binding kinetic models; (3) cellular signaling models and (4) a proprietary neural circuit model to quantitate the drug effects on the activity of relevant brain neuronal networks, that also adequately predicts clinical outcome.

To develop the QSPainrelief platform, a large dataset assessing perceived clinical outcome by real-world patients treated with a drug combination and stratified according to age and sex is required. To generate this dataset, we will conduct a questionnaire-based clinical study using an online platform (Redcap) and/or phone interviews to assess baseline patient characteristics and clinical outcome. Eligible patients are any patient treated with an opioid analgesic to whom an add-on treatment acting on the CNS is prescribed.

This study will focus on pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation, drug-induced cognitive dysfunction (memory and attention) and pain medication misuse as adverse effects. These adverse effects have been chosen because they can be readily assessed in patients after a short treatment period using validated patient-reported outcome measures (PROMs).

QSPainRelief-patientSTRAT is a monocentric prospective longitudinal questionnaire-based study conducted in patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment).

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: André Mouraux, Professor; Phone Number: 0032496232399; Email: andre.mouraux@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged over 18 years.
2. Current treatment with an opioid for the treatment of pain, along with possible other drugs (see Table 1 for the list of eligible opioid medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
3. Decision by the treating physician to introduce an additional non-opioid CNS-acting treatment such as an antiepileptic, an anti-depressant or benzodiazepine (see Table 2 for the list of eligible medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
4. Capacity to understand and provide informed consent.

Exclusion Criteria:

1. Insufficient French language skills.
2. Epilepsy treated by an anti-epileptic.
3. Alzheimer's disease.
4. Parkinson's disease
5. History of cancer diagnosed less than 5 years ago, treated by chemotherapy or radiotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Peristent Pain Patients; Patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment), will be included. Evaluation of drug combination pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation and drug-induced cognitive dysfunction (memory and attention) as adverse effects will be evaluated through online (REDCap) patient-reported outcomes at the beginning of the study (day 0), 10 days and 3 months.

Combination product: Opioid drug + CNS-acting add-on drug; Patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	The intensity of pain at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences pain relief, expressed as change in pain severity score from Day 0 to Day 10 and Month 3 realized with the Brief Pain Inventory (SF-BPI) pain severity score.	10 days and 3 months
Daily Life Activities	The impact on daily life activities at 10 days and 3 months post-drug combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences daily activities, expressed as change in daily life activities score from Day 0 to Day 10, and Month 3, realized with the Brief Pain Inventory (SF-BPI) daily life activities score.	10 days and 3 months
Quality of Life (EURO-QoL)	The impact on quality of life at 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences quality of life, expressed as change in EuroQOL-5D score from Day 0 to Month 3.	3 months
Drug-induced sedation	Drug-induced sedation at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences sleepiness, expressed as change in the Stanford Sleepiness Scale score from Day 0 to Day 10 and Month 3	10 days and 3 months
Drug-induced cognitive dysfunction	. Drug-induced cognitive dysfunction (memory and attention) at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences cognitive functions, expressed as change in the PROMIS Neuro-QOL Short Form Cognitive Function score from Day 0 to Day 10 and Month 3.	10 days and 3 months

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pain; Neurologic Manifestations; Chronic Pain; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 2023/13/JUI/259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No