Cross-cultural Validation of a Screening Scale for the Misuse of Opioid Analgesics in Primary Care

NCT05431985 | Completed

• 1 other identifier: 2015 LAPORTE
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 5

Brief Summary

Objective: Analgesic Opioids misuse among patients with chronic pain ranges from 0% to 50%. The general practitioner is the first prescriber of opioid analgesics Our objective was to validate in primary care the POMI (Prescription Opioid Misuse Index) to identify the misuse of AOs. Study Setting: Patients with chronic pain, taking AOs for at least 3 months, and followed in general practice. Study design: Psychometric study Data Collection/Extraction methods: Eligible patients followed in general practice responded to the POMI: Test phase. They then responded after 2 weeks: the retest. The gold standard used was the DSM-V.

Conditions

Chronic Pain; Addiction Opiate

Keywords

chronic pain; opioids; primary care; misuse; addiction

Outcome Measures

Primary Outcomes (2)

• Prescription Opioid Misuse Index - POMI

  Prescription Opioid Misuse Index (POMI) scale was developed in the United States to assess the oxycodone misuse. This scale was validated among 137 subjects recruited from pain clinics, addiction treatment programs, jails, or private medical practice. The POMI is an 8 point self-assessment scale each numbered 0 (absence) or 1 (presence). The sum of point is used to calculate a score (between 0 and 8) and a score of more or equal to 2 is considered as positive and describe a misuse.

  at inclusion

• Prescription Opioid Misuse Index - POMI

  Prescription Opioid Misuse Index (POMI) scale was developed in the United States to assess the oxycodone misuse. This scale was validated among 137 subjects recruited from pain clinics, addiction treatment programs, jails, or private medical practice. The POMI is an 8 point self-assessment scale each numbered 0 (absence) or 1 (presence). The sum of point is used to calculate a score (between 0 and 8) and a score of more or equal to 2 is considered as positive and describe a misuse.

  2 weeks after the first completion

Secondary Outcomes (1)

• Sociodemographic characteristics

  once, at inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patients with chronic pain for at least 6 months, and with a prescription from the general practitioners of at least one opioid analgesic drug taken daily for at least the previous 3 months.

You may qualify if:

• Patients aged 18 and over,
• Patients with chronic pain for at least 6 months,
• Patients with a prescription from the GP of at least one Opioid analgesic drug taken daily for at least the previous 3 months,
• Patients registered with the French insurance system.

You may not qualify if:

• Discontinuation of opioid prescriptions on the test phase day (no Retest possible),
• Patients in the process of withdrawal (risk of having been withdrawn during the Retest phase),
• Patients unable to complete the questionnaire alone,
• Patients who are monitored by a pain clinic or addiction centre,
• Patients with ongoing cancer,
• Patients refusing to participate.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (5)

CHU Clermont-Ferrand, UMR INSERM 1107, NEURO-DOL

Clermont-Ferrand, France

Location

Département de médecine Générale, Facultés de Médecine de Clermont-Ferrand

Clermont-Ferrand, France

Location

Département de médecine générale, Lyon

Lyon, France

Location

Département de médecine générale, Faculté de médecine, Montpellier

Montpellier, France

Location

Département de médecine générale, Faculté de médecine, Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: January 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)