Prescription Opioid Misuse Assessment (POMA4)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Prescription Opioid Misus Index

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 Type: Observational
• Enrollment (Actual): 951

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic non-cancer pain; Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	age, gender, family situation, employment status) and clinical data (type of pain, age of painful pathology, psychiatric comorbidities, abuse of other substances, etc	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: CEIP-A Lyon; CEIP-A Marseille; CEIP-A Caen; CEIP-A Lille; CEIP-A Montpellier; CEIP-A Nantes; CEIP-A Poitiers; CEIP-A Toulouse; CEIP-A Bordeaux
• Investigators: Principal Investigator: Nicolas AUTHIER, CHU de Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2018
• Primary Completion (Actual): July 9, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Misuse; Analgesic opioids; Use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Chronic Pain; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: CHU-338; 2016-A00648-43 (Other Identifier: 2016-A00648-43)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No