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Prescription Opioid Misuse Assessment (POMA 4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195374
Recruitment Status : Unknown
Verified June 2017 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Chronic Pain 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.

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Study Type : Observational
Estimated Enrollment : 1068 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of the Prevalence of Analgesics Opioid Misuse in Chronic Non-cancer Pain Patients
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.




Primary Outcome Measures :
  1. Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale [ Time Frame: at day 1 ]
    A score ≥ 2 is considered positive and will define a misuse behavior


Secondary Outcome Measures :
  1. Analgesic opioids used by the patient will be collected in the questionnaire [ Time Frame: at day 1 ]
  2. Patients' profiles and associated risk factors of opioid misuse will be described through socio-demographic contained in the questionnaire [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195374


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Nicolas AUTHIER         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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
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Principal Investigator: Nicolas AUTHIER CHU de Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03195374    
Other Study ID Numbers: CHU-338
2016-A00648-43 ( Other Identifier: 2016-A00648-43 )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Analgesic opioids
Misuse
Use disorder
Pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents