Prescription Opioid Misuse Assessment

Chronic Pain Clinical Trial

— POMA4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195374
• Other study ID #: CHU-338
• Secondary ID: 2016-A00648-43
• Status: Completed
• Start date: August 24, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: April 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 951
• Est. completion date: July 30, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (10)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analgesic opioids used by the patient will be collected in the questionnaire		at day 1
Secondary	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