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

NCT ID: NCT03498014

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Non-cancerous Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Prescription as standard

Group Type ACTIVE_COMPARATOR

Standard opioid prescription

Intervention Type OTHER

Opioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone)

Pharmacogenetic-guided prescription

Group Type EXPERIMENTAL

Pharmacogenetic analysis allowing personalized opioid prescription

Intervention Type OTHER

Genotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone)

Interventions

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Pharmacogenetic analysis allowing personalized opioid prescription

Genotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone)

Intervention Type OTHER

Standard opioid prescription

Opioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone)

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe Boyer

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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NIMAO/2017-02/JCB-01

Identifier Type: -

Identifier Source: org_study_id

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