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Prescription Opioid Misuse Assessment

Assessment of the Prevalence of Analgesics Opioid Misuse in Chronic Non-cancer Pain Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03195374
Acronym
POMA4
Enrollment
951
Registered
2017-06-22
Start date
2018-08-24
Completion date
2019-07-30
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Analgesic opioids, Misuse, Use disorder, Pain

Brief summary

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

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.

Interventions

OTHERPrescription 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.

Sponsors

CEIP-A Lyon
CollaboratorUNKNOWN
CEIP-A Marseille
CollaboratorUNKNOWN
CEIP-A Caen
CollaboratorUNKNOWN
CEIP-A Lille
CollaboratorUNKNOWN
CEIP-A Montpellier
CollaboratorUNKNOWN
CEIP-A Nantes
CollaboratorUNKNOWN
CEIP-A Poitiers
CollaboratorUNKNOWN
CEIP-A Toulouse
CollaboratorUNKNOWN
CEIP-A Bordeaux
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scaleat day 1A score ≥ 2 is considered positive and will define a misuse behavior

Secondary

MeasureTime frameDescription
Analgesic opioids used by the patient will be collected in the questionnaireat day 1
Patients' profiles and associated risk factors of opioid misuse will be described through socio-demographic contained in the questionnaireat day 1age, gender, family situation, employment status) and clinical data (type of pain, age of painful pathology, psychiatric comorbidities, abuse of other substances, etc

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026