Chronic PainPOMA4NCT03195374
Prescription Opioid Misuse Assessment
An observational study of Chronic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Prescription Opioid Misus Index
- How many people
- 951 participants
- Where
- 1 siteFrance
- Study dates
- 24 Aug 2018to 30 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Prevalence of Analgesics Opioid Misuse in Chronic Non-cancer Pain Patients
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Prescription Opioid Misus Index
- Keywords
- Analgesic opioids, Misuse, Use disorder, Pain
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic non-cancer pain | Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria. Receives: Other: Prescription Opioid Misus Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1
Secondary outcomes (2)
Analgesic opioids used by the patient will be collected in the questionnaire
Measured: at day 1
Patients' profiles and associated risk factors of opioid misuse will be described through socio-demographic contained in the questionnaire
age, gender, family situation, employment status) and clinical data (type of pain, age of painful pathology, psychiatric comorbidities, abuse of other substances, etc
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start24 Aug 2018
- Primary completion9 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 951 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Nicolas AUTHIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195374
- Sponsor's protocol ID
- CHU-338
- Other IDs
- 2016-A00648-43
- Acronym
- POMA4
- Status last verified
- Apr 2022
- First submitted
- 12 Jun 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36133827
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence of Analgesics Opioid Misuse in Chronic Non-cancer Pain Patients
- ClinicalTrials.gov ID
- NCT03195374
- Acronym / sponsor ID
- POMA4 / CHU-338
- Conditions
- Chronic Pain
- Keywords
- Analgesic opioids, Misuse, Use disorder, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 951 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 22 Jun 2017 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic non-cancer pain | – | Other: Prescription Opioid Misus IndexEach addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription Opioid Misus IndexOpioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale. A score ≥ 2 is considered positive and will define a misuse behavior. | Other | Patients with chronic non-cancer pain |
Primary outcome
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
2 secondary outcomes
Analgesic opioids used by the patient will be collected in the questionnaire
Time frame: at day 1
Patients' profiles and associated risk factors of opioid misuse will be described through socio-demographic contained in the questionnaire
Time frame: at day 1
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 21 Apr 2022.
- Derived from this study: PubMed 36133827Kerckhove 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.
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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.
Nicolas AUTHIER principal investigator
University Hospital, Clermont-Ferrand
1 site 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, run by University Hospital, Clermont-Ferrand at 1 site 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 3 inclusion and 4 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195374, which also lists 1 linked publication.
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 21 Apr 2022.