Clinical trial NCT03498014: Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
Official title: Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-cancerous Chronic Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Compare presence/absence undesirable events associated to opioid between groups from predefined list
timeFrame: Month 1
measure: Compare presence/absence undesirable events associated to opioid between groups from predefined list
timeFrame: Month 2
measure: Compare presence/absence undesirable events associated to opioid between groups from predefined list
timeFrame: Month 3
measure: Compare presence/absence undesirable events associated to opioid between groups
timeFrame: Month 1
measure: Compare presence/absence undesirable events associated to opioid between groups
timeFrame: Month 2
measure: Compare presence/absence undesirable events associated to opioid between groups
timeFrame: Month 3
Secondary outcomes:
measure: Number of undesirable events associated to opioid between groups
timeFrame: Month 1
measure: Number of undesirable events associated to opioid between groups
timeFrame: Month 2
measure: Number of undesirable events associated to opioid between groups
timeFrame: Month 3
measure: Number of undesirable events associated to opioid between groups
timeFrame: Month 1
measure: Number of undesirable events associated to opioid between groups
timeFrame: Month 2
measure: Number of undesirable events associated to opioid between groups
timeFrame: Month 3
measure: Compare clinical therapeutic efficacy between groups
timeFrame: Month 1
measure: Compare clinical therapeutic efficacy between groups
timeFrame: Month 2
measure: Compare clinical therapeutic efficacy between groups
timeFrame: Month 3
measure: Compare patient-reported pain between groups
timeFrame: Day 0
measure: Compare patient-reported pain between groups
timeFrame: Week 2
measure: Compare patient-reported pain between groups
timeFrame: Month 1
measure: Compare patient-reported pain between groups
timeFrame: Month 2
measure: Compare patient-reported pain between groups
timeFrame: Month 3
measure: Compare neuropathic pain between groups
timeFrame: Day 0
measure: Compare neuropathic pain between groups
timeFrame: Month 1
measure: Compare neuropathic pain between groups
timeFrame: Month 2
measure: Compare neuropathic pain between groups
timeFrame: Month 3
measure: Compare benefit/risk ratio of treatment between groups
timeFrame: Month 1
measure: Compare benefit/risk ratio of treatment between groups
timeFrame: Month 2
measure: Compare benefit/risk ratio of treatment between groups
timeFrame: Month 3
measure: Compare quality of life between patients in each group
timeFrame: Day 0
measure: Compare quality of life between patients in each group
timeFrame: Month 3
measure: Compare medication compliance between groups
timeFrame: Month 1
measure: Compare medication compliance between groups
timeFrame: Month 2
measure: Compare medication compliance between groups
timeFrame: Month 3
measure: Qualitive comparison of medication compliance between groups
timeFrame: Month 1
measure: Qualitive comparison of medication compliance between groups
timeFrame: Month 2
measure: Qualitive comparison of medication compliance between groups
timeFrame: Month 3
measure: Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
timeFrame: Day 0
measure: Compare observed medication misuse between groups
timeFrame: Month 1
measure: Compare observed medication misuse between groups
timeFrame: Month 2
measure: Compare observed medication misuse between groups
timeFrame: Month 3
measure: Correlation between predicted phenotype and observed metabolic ratios
timeFrame: Month 1
measure: Correlation between predicted phenotype and observed metabolic ratios
timeFrame: Month 2
measure: Correlation between predicted phenotype and observed metabolic ratios
timeFrame: Month 3
measure: Metabolic profile of patients
timeFrame: Month 1
measure: Metabolic profile of patients
timeFrame: Month 2
measure: Metabolic profile of patients
timeFrame: Month 3
measure: Correlation between saliva and plasma concentration of opioids
timeFrame: Month 1
measure: Correlation between saliva and plasma concentration of opioids
timeFrame: Month 2
measure: Correlation between saliva and plasma concentration of opioids
timeFrame: Month 3
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Jean-Christophe Boyer
role: PRINCIPAL_INVESTIGATOR
References: