Prescription Opioid Misuse Assessment

Completed

• Conditions: Chronic Pain
• Interventions: Other: Prescription Opioid Misus Index

• Registration Number: NCT03195374
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Study Start: 2018-08-24
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 951

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic non-cancer pain	Prescription Opioid Misus Index	Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria.

Primary Outcome Measures

Name	Time	Method
Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale	at day 1	A score ≥ 2 is considered positive and will define a misuse behavior

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France