NCT03195374

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
951

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 24, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

June 12, 2017

Last Update Submit

April 14, 2022

Conditions

Chronic Pain

Keywords

Analgesic opioidsMisuseUse disorderPain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

    at day 1

Study Arms (1)

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

Interventions

Prescription Opioid Misus IndexOTHER

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.

Patients with chronic non-cancer pain

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 36133827DERIVED

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas AUTHIER

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 22, 2017

Study Start

August 24, 2018

Primary Completion

July 9, 2019

Study Completion

July 30, 2019

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations

FR(1)