QSPainRelief-STRAT

NCT06244706 | Unknown

• 1 other identifier: 2023/13/JUI/259
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Pain; Analgesia; Adverse Drug Event; Drug Interaction

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Peristent Pain Patients

OTHER

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

Interventions

Opioid drug + CNS-acting add-on drug COMBINATION_PRODUCT

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).

Peristent Pain Patients

Eligibility Criteria

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

You may qualify if:

• Aged over 18 years.
• 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).
• 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).
• Capacity to understand and provide informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

MeSH Terms

Conditions

Chronic Pain; Agnosia; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Chemically-Induced Disorders

Central Study Contacts

André Mouraux, Professor

CONTACT

0032496232399; andre.mouraux@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2024

Record last verified: 2023-12