Clinical trial NCT03195374: Prescription Opioid Misuse Assessment
Official title: Assessment of the Prevalence of Analgesics Opioid Misuse in Chronic Non-cancer Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Analgesic opioids
Misuse
Use disorder
Pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: CEIP-A Lyon
name: CEIP-A Marseille
name: CEIP-A Caen
name: CEIP-A Lille
name: CEIP-A Montpellier
name: CEIP-A Nantes
name: CEIP-A Poitiers
name: CEIP-A Toulouse
name: CEIP-A Bordeaux
First posted: 2017-06-22
Enrollment: 951
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale
timeFrame: at day 1
Secondary outcomes:
measure: Analgesic opioids used by the patient will be collected in the questionnaire
timeFrame: at day 1
measure: Patients' profiles and associated risk factors of opioid misuse will be described through socio-demographic contained in the questionnaire
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Nicolas AUTHIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.