Chronic Non Cancer PainNCT04544696
Pharmacist for Detecting Opioid Misuse
An observational study of Chronic Non Cancer Pain, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Opioid use is increasing in Western countries and is associated with harms as hospitalization, addiction and deaths(1). Community pharmacists interact frequently with patients, giving them the opportunity to identify and prevent the risk of prescribed opioid misuse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non Cancer Pain
- How many people
- 414 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2019to 1 Jun 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: Patients with chronic non cancer pain
Who may be able to join
- -Collection of the questionnaire in a community pharmacy of the area of investigation East-Occitania)
- Patient over 18 years of age
- Suffering from pain (CNCP) (> 3 months old)
- Treated with weak or strong opioids
Who cannot join
- Collection of the questionnaire in a community pharmacy outside Eastern Occitania
- Patient under 18 years of age
- Suffering from acute pain (< 3 months old) or cancerous pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacists in Detecting Opioid Misuse Using the Prescription Opioid Misuse Index (POMI): Survey in a Region in the South of France, Occitanie-Est
Opioid use is increasing in Western countries and is associated with harms as hospitalization, addiction and deaths(1). Community pharmacists interact frequently with patients, giving them the opportunity to identify and prevent the risk of prescribed opioid misuse. The purpose of this study was therefore to assess the risk of prescribed opioids misuse in ambulatory patients with chronic non-cancer pain (CNCP) seen in community pharmacies.
Method: A questionnaire (including the Prescription Opioid Misuse POMI(2)) have been proposed to patients with opioid prescription by pharmacy students, in 86 pharmacies of Occitanie-Est, in April 2019. Eligible patients were adults with CNCP that consented to participate.
Read more
A total of 414 patients (62.4% women, mean age 58 ± 16.00) have been included. The main pains were spinal (37.3%) and osteoarticular (33.1%). The median visual analog scale (VAS) was 7 [IQR25-75: 5-8]. The prescribed opioids are mainly weak opioids (73.2%): paracetamol/tramadol (35%), paracetamol/codeine (17.4%), paracetamol/opium (16.8%). Strong opioids (32.6%) were oxycodone (11.95%), fentanyl (9%), and morphine (9%). The median morphine milligram equivalent (MME) was 40 mg/day [IQR25-75: 20-80].
POMI score was superior to 2/6 in 45.4% and superior to 4 in 16%. The main positive question were feel high (40.3%), take the opioid more often (39.3%), take more medication (36.6), and need to early renew opioid medication earlier (30.8%).
Patients with POMI score > 4 were younger (49 years versus 55.9; p<0.01), more urban (78.1% versus 69.2%; p=0.03), had higher VAS (7.3 versus 6.2; p<0.01), received higher median MME (112 mg versus 64.9 mg; p<0.01), and consumed more strong opioid (45.3% versus 27.3%; p=0.04).
- Conditions
- Chronic Non Cancer Pain
- Keywords
- Opioid, Misuse, Community pharmacy, POMI test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic non cancer pain | Patients with chronic non cancer pain, treated with opioids and having completed the POMi questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with POMI test "Prescribed Opioid Misuse Index"> 2
Patients with POMI test > 2 A score >2, may be associated with a risk of misuse of opioid medication. It is recommended to discuss this with the physician
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start17 Apr 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non Cancer 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Peyrière, PH, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544696
- Sponsor's protocol ID
- RECHMPL20_0433
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacists in Detecting Opioid Misuse Using the Prescription Opioid Misuse Index (POMI): Survey in a Region in the South of France, Occitanie-Est
- ClinicalTrials.gov ID
- NCT04544696
- Acronym / sponsor ID
- RECHMPL20_0433
- Conditions
- Chronic Non Cancer Pain
- Keywords
- Opioid, Misuse, Community pharmacy, POMI test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 10 Sep 2020 (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.
Opioid use is increasing in Western countries and is associated with harms as hospitalization, addiction and deaths(1). Community pharmacists interact frequently with patients, giving them the opportunity to identify and prevent the risk of prescribed opioid misuse. The purpose of this study was therefore to assess the risk of prescribed opioids misuse in ambulatory patients with chronic non-cancer pain (CNCP) seen in community pharmacies.
Method: A questionnaire (including the Prescription Opioid Misuse POMI(2)) have been proposed to patients with opioid prescription by pharmacy students, in 86 pharmacies of Occitanie-Est, in April 2019. Eligible patients were adults with CNCP that consented to participate.
A total of 414 patients (62.4% women, mean age 58 ± 16.00) have been included. The main pains were spinal (37.3%) and osteoarticular (33.1%). The median visual analog scale (VAS) was 7 [IQR25-75: 5-8]. The prescribed opioids are mainly weak opioids (73.2%): paracetamol/tramadol (35%), paracetamol/codeine (17.4%), paracetamol/opium (16.8%). Strong opioids (32.6%) were oxycodone (11.95%), fentanyl (9%), and morphine (9%). The median morphine milligram equivalent (MME) was 40 mg/day [IQR25-75: 20-80].
POMI score was superior to 2/6 in 45.4% and superior to 4 in 16%. The main positive question were feel high (40.3%), take the opioid more often (39.3%), take more medication (36.6), and need to early renew opioid medication earlier (30.8%).
Patients with POMI score > 4 were younger (49 years versus 55.9; p<0.01), more urban (78.1% versus 69.2%; p=0.03), had higher VAS (7.3 versus 6.2; p<0.01), received higher median MME (112 mg versus 64.9 mg; p<0.01), and consumed more strong opioid (45.3% versus 27.3%; p=0.04).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic non cancer pain | – | –Patients with chronic non cancer pain, treated with opioids and having completed the POMi questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic non cancer pain
Key inclusion criteria (4 listed)
- -Collection of the questionnaire in a community pharmacy of the area of investigation East-Occitania)
- Patient over 18 years of age
- Suffering from pain (CNCP) (> 3 months old)
- Treated with weak or strong opioids
Key exclusion criteria (3 listed)
- Collection of the questionnaire in a community pharmacy outside Eastern Occitania
- Patient under 18 years of age
- Suffering from acute pain (< 3 months old) or cancerous pain
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
Patients with POMI test "Prescribed Opioid Misuse Index"> 2
Time frame: 1 day
Patients with POMI test > 2 A score >2, may be associated with a risk of misuse of opioid medication. It is recommended to discuss this with the physician
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 14 Sep 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Chronic Non Cancer Pain
Not yet recruiting
The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study
Back Pain
Recruiting
Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care
Chronic Pain, Chronic Pain Management
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Not yet recruitingPhase 1
A Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection in Participants With Moderate-to-Severe Non-Cancer Chronic Pain
Chronic Pain
Recruiting
Preventive Interventions for Chronic Pain Worsening
Chronic Non-Cancer Pain
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.
Hélène Peyrière, PH principal investigator
UH Montpellier
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 Non Cancer Pain, run by University Hospital, Montpellier 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 4 inclusion and 3 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 14 Sep 2020. 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?
Patients with POMI test "Prescribed Opioid Misuse Index"> 2 (time frame: 1 day). 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 14 Sep 2020.