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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03195374
Other study ID # CHU-338
Secondary ID 2016-A00648-43
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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