Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.

Not Applicable

Withdrawn

• Conditions: Non-cancerous Chronic Pain

• Registration Number: NCT03498014
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Study Start: 2022-07
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is at least 18 years old
• The patient will be available for all visits
• Patients suffer from non-cancerous chronic pain according to HAS criteria
• Patient not having taking opioids in previous 2 months
• Patient indicated for prescription of opioids (oxycodone, codeine or tramadol) or patient not responding to first line treatment

Exclusion Criteria

• The subject is participating in an category I interventional study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• The patient is pregnant or breastfeeding
• The patient is likely to procreate and does not use an effective method of contraception (contraceptive ring, surgical contraception, implant, patch, contraceptive pill, male and female condoms, IUD)
• There is a contra-indication for opioid use
• Patient with an addiction risk (score ≥ 8 on ORT scale).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare presence/absence undesirable events associated to opioid between groups from predefined list	Month 3	Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol
Compare presence/absence undesirable events associated to opioid between groups	Month 3	Presence/absence of at least one undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Secondary Outcome Measures

Name	Time	Method
Number of undesirable events associated to opioid between groups	Month 3	Total number of undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Compare benefit/risk ratio of treatment between groups	Month 3	Overall Benefit of Analgesics Score (OBAS); score between 0-32
Compare quality of life between patients in each group	Month 3	Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Qualitive comparison of medication compliance between groups	Month 3	Presence/absence of opioids or metabolites in serum
Compare patient-reported pain between groups	Month 3	Visual analog scare 1-10
Compare neuropathic pain between groups	Month 3	DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Correlation between predicted phenotype and observed metabolic ratios	Month 3	Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
Metabolic profile of patients	Month 3	Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7
Correlation between saliva and plasma concentration of opioids	Month 3	Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Compare medication compliance between groups	Month 3	Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Compare observed medication misuse between groups	Month 3	Prescription Opioid Misuse Index (POMI)
Compare clinical therapeutic efficacy between groups	Month 3	Patient Global Impression of Change (PGIC) score; value between 1-7
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)	Day 0	Opioids Risk Tool (ORT): scores of 0-3 (low risk), 4-7 (moderate risk), or ≥ 8 (high risk)

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France