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Completed

NCT Number: NCT03195374

Prescription Opioid Misuse Assessment

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prescription Opioid Misus Index

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: POMA4

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2017
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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