Chronic PainVAMOSNCT05431985
Cross-cultural Validation of a Screening Scale for the Misuse of Opioid Analgesics in Primary Care
An observational study of Chronic Pain and Addiction Opiate, run by University Hospital, Clermont-Ferrand at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Addiction Opiate
- How many people
- 160 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Jan 2017to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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- Patients in the process of withdrawal (risk of having been withdrawn during the Retest phase),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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Clermont-Ferrand, UMR INSERM 1107, NEURO-DOL
Clermont-Ferrand
Département de médecine Générale, Facultés de Médecine de Clermont-Ferrand
Clermont-Ferrand
Département de médecine générale, Lyon
Lyon
Département de médecine générale, Faculté de médecine, Montpellier
Montpellier
Département de médecine générale, Faculté de médecine, Toulouse
Toulouse
About this study
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.
Read the detailed description
Chronic pain represents a major problem in terms of individual, quality of life, and collective impact: cost generated by delays in treatment and care. The prevalence of chronic pain among the general population varies from 10.1 to 55.2%. In the front line, general practitioners (GP) are at the heart of treating pain : pain represent 43% of the reasons for the consultation, 24% of these being for chronic pain. More than half of these patients had exclusive care through their GP. The others are followed up in a pain assessment and treatment center.
In 2015, nearly one in five French people (17,1%) of French people have taken opioid treatment. The risk of opioid use disorder secondary to opioid analgesics among patients suffering from chronic pain varies from 0% to 50%. American recommendations advocate periodic surveillance of this opioid use disorder depending on the patient's risk factors, when chronic opioid analgesics are prescribed. The French "Limoges" recommendations also mention a systematic search for signs of psychological dependence during treatment and state that treatment with strong opioids should be stopped in the event of misuse, abuse or addiction. They recommend, on each examination, the investigation for signs of misuse or psychological dependence (characterised by craving) as ways of monitoring that strong opioids are being correctly used in chronic osteo-articular pain.
Identifying the misuse is a way of optimising their benefit/risk ratio
The difficulty in establishing the prevalence of misuse is due to a lack of standardization of studies and the lack of consensus in the use of assessment tools. Several tools are available internationally. The only diagnostic criteria available are those of the DSM-5 (Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders) or the ICD-10 which overestimate this prevalence notably by the presence of frequent tolerance and withdrawal criteria for these patients, in the absence of misuse or addiction. Today, no screening scale has been validated in France for primary care, but recently, the authors have validated the POMI scale in French to screen the patients specifically followed in pain clinic and presenting a misuse behavior of their opioid analgesic treatment. In 2015, treatment initiation was carried out by a GP in 59.1% of cases for weak opioid and 62.9% of cases for strong opioids and by a hospital doctor for 20.1% and 21% respectively7. Currently, no scale was validated in primary care. A scale validated in French would make it possible to standardize these screening practices and secure prescription both from the point of view of the doctor and of the patient. Furthermore, this absence of a validated tool in French is proving to be an obstacle to the development of true pharmaco-epidemiological studies on the prevalence of the opioids misuse. The originality of this study is to assess the clinical relevance of the french transcultural validation of the POMI scale in primary care in order to ensure an appropriate and relevant use by all health professionals and to allow large-scale screening for the misuse behavior of analgesic opioids.
The aim of the study was a validation of the French version of the Prescription Opioid Misuse Index - POMI patients with chronic pain in general practitioners setting.
Secondary objective
- To study the profile of participants with misuse of opioid analgesics.
- To compare the results of this study with the previous study on patients followed in pain clinic.
- Conditions
- Chronic Pain, Addiction Opiate
- Keywords
- chronic pain, opioids, primary care, misuse, addiction
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders, Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks after the first completion
Secondary outcomes (1)
Sociodemographic characteristics
GPs asked patients about sociodemographic data (age, gender, family status, professional status); medical and family medical history; history of psychiatric problem, substance use and abuse.
Measured: once, at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jan 2017
- Primary completion1 Mar 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431985
- Sponsor's protocol ID
- 2015 LAPORTE
- Acronym
- VAMOS
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Validation of a Screening Scale for the Misuse of Opioid Analgesics in Primary Care
- ClinicalTrials.gov ID
- NCT05431985
- Acronym / sponsor ID
- VAMOS / 2015 LAPORTE
- Conditions
- Chronic Pain, Addiction Opiate
- Keywords
- chronic pain, opioids, primary care, misuse, addiction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic pain represents a major problem in terms of individual, quality of life, and collective impact: cost generated by delays in treatment and care. The prevalence of chronic pain among the general population varies from 10.1 to 55.2%. In the front line, general practitioners (GP) are at the heart of treating pain : pain represent 43% of the reasons for the consultation, 24% of these being for chronic pain. More than half of these patients had exclusive care through their GP. The others are followed up in a pain assessment and treatment center.
In 2015, nearly one in five French people (17,1%) of French people have taken opioid treatment. The risk of opioid use disorder secondary to opioid analgesics among patients suffering from chronic pain varies from 0% to 50%. American recommendations advocate periodic surveillance of this opioid use disorder depending on the patient's risk factors, when chronic opioid analgesics are prescribed. The French "Limoges" recommendations also mention a systematic search for signs of psychological dependence during treatment and state that treatment with strong opioids should be stopped in the event of misuse, abuse or addiction. They recommend, on each examination, the investigation for signs of misuse or psychological dependence (characterised by craving) as ways of monitoring that strong opioids are being correctly used in chronic osteo-articular pain.
Identifying the misuse is a way of optimising their benefit/risk ratio
The difficulty in establishing the prevalence of misuse is due to a lack of standardization of studies and the lack of consensus in the use of assessment tools. Several tools are available internationally. The only diagnostic criteria available are those of the DSM-5 (Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders) or the ICD-10 which overestimate this prevalence notably by the presence of frequent tolerance and withdrawal criteria for these patients, in the absence of misuse or addiction. Today, no screening scale has been validated in France for primary care, but recently, the authors have validated the POMI scale in French to screen the patients specifically followed in pain clinic and presenting a misuse behavior of their opioid analgesic treatment. In 2015, treatment initiation was carried out by a GP in 59.1% of cases for weak opioid and 62.9% of cases for strong opioids and by a hospital doctor for 20.1% and 21% respectively7. Currently, no scale was validated in primary care. A scale validated in French would make it possible to standardize these screening practices and secure prescription both from the point of view of the doctor and of the patient. Furthermore, this absence of a validated tool in French is proving to be an obstacle to the development of true pharmaco-epidemiological studies on the prevalence of the opioids misuse. The originality of this study is to assess the clinical relevance of the french transcultural validation of the POMI scale in primary care in order to ensure an appropriate and relevant use by all health professionals and to allow large-scale screening for the misuse behavior of analgesic opioids.
The aim of the study was a validation of the French version of the Prescription Opioid Misuse Index - POMI patients with chronic pain in general practitioners setting.
Secondary objective
- To study the profile of participants with misuse of opioid analgesics.
- To compare the results of this study with the previous study on patients followed in pain clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prescription Opioid Misuse Index - POMI
Time frame: at inclusion
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.
Prescription Opioid Misuse Index - POMI
Time frame: 2 weeks after the first completion
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.
1 secondary outcome
Sociodemographic characteristics
Time frame: once, at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Addiction Opiate, run by University Hospital, Clermont-Ferrand at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription Opioid Misuse Index - POMI (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.