Prescription Opioid Misuse Assessment

NCT ID: NCT03195374

Last Updated: 2022-04-21

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

COMPLETED

Total Enrollment

951 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-24

Study Completion Date

2019-07-30

Brief Summary

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Chronic pain is a worldwide health problem due to its high prevalence and its difficult management with a significant impact on quality of life. Pain and addiction co-occur frequently. Indeed, the prevalence of addiction in patients with chronic non-cancer pain may affect from 0% to 50% of patients (Højsted et al 2010). This large variability in the estimation of addiction prevalence in chronic non-cancer pain patients is at least partly due to a lack of standardization of the selected patients from the clinical or therapeutic point of view and the lack of consensus in the use of a specific evaluation tool or gold standard. Indeed, several tools are currently available at the international level with varying efficiencies and precisions (Chou et al 2009, Turk, Swanson, and Gatchel 2008, Højsted and Sjøgren 2007). In France, no data are available on the prevalence of analgesic opioid misuse in chronic non-cancer pain patients, due to the lack clinical studies and validated tools in French.

Detailed Description

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This is an observational study . Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria. The questionnaires will be prepared and sent to the participating centres by the coordinating centre (Clermont-Ferrand). Participation in the study will be systematically proposed by the physician during the study inclusion period (3 months). Patients meeting all inclusion criteria will be enrolled after receiving oral information about the study.

This questionnaire can be semi-directed (doctor / nurse / CRA) and will be carried out during a consultation as part of their usual care. Answering the questionnaire should take no more than 10 minutes. No additional diagnostic or monitoring procedures will be applied to patients.

Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic non-cancer pain

Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria.

Prescription Opioid Misus Index

Intervention Type OTHER

Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale. A score ≥ 2 is considered positive and will define a misuse behavior.

Interventions

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Prescription Opioid Misus Index

Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale. A score ≥ 2 is considered positive and will define a misuse behavior.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients (male or female) ≥ 18 years old
* Patients with chronic non-cancer pain for at least 6 months
* Patients treated with analgesic opioids for at least 3 months

Exclusion Criteria

* Patients (male or female) \< 18 years old
* Patients with chronic pain for less than 6 months
* Patients with cancer pain
* Patients treated with analgesic opioids for less than 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CEIP-A Lyon

UNKNOWN

Sponsor Role collaborator

CEIP-A Marseille

UNKNOWN

Sponsor Role collaborator

CEIP-A Caen

UNKNOWN

Sponsor Role collaborator

CEIP-A Lille

UNKNOWN

Sponsor Role collaborator

CEIP-A Montpellier

UNKNOWN

Sponsor Role collaborator

CEIP-A Nantes

UNKNOWN

Sponsor Role collaborator

CEIP-A Poitiers

UNKNOWN

Sponsor Role collaborator

CEIP-A Toulouse

UNKNOWN

Sponsor Role collaborator

CEIP-A Bordeaux

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas AUTHIER

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status

Countries

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France

References

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Kerckhove N, Delage N, Bertin C, Kuhn E, Cantagrel N, Vigneau C, Delorme J, Lambert C, Pereira B, Chenaf C, Authier N; Poma Network. Cross-sectional study of the prevalence of prescription opioids misuse in French patients with chronic non-cancer pain: An update with the French version of the POMI scale. Front Pharmacol. 2022 Sep 5;13:947006. doi: 10.3389/fphar.2022.947006. eCollection 2022.

Reference Type DERIVED
PMID: 36133827 (View on PubMed)

Other Identifiers

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2016-A00648-43

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-338

Identifier Type: -

Identifier Source: org_study_id

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