Pain, ChronicDISCORDANCENCT03346408
Dependence on Analgesics in Chronic Non-cancer Pain
An observational study of Pain, Chronic, run by University Hospital, Toulouse at 7 sites in France.
Trial summary
The identification of an addiction to opioid analgesics has become strong recommendation for the purpose of improving the clinical management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 7 sitesFrance
- Study dates
- 4 Nov 2017to 18 Dec 2018
- 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: Physician and patients recruited in pain consultations and treatment structures
Who may be able to join
- suffering from chronic non-cancer pain,
- taking at least one analgesic medication
Who cannot join
- Patient minor or major protected by the law (under tutelage),
- Patient with chronic pain of cancerous origin,
- Opposition of the patient to be included in the study,
- Patient not having the overall skills to complete a self-questionnaire: major difficulties in understanding the French language and / or reading / writing difficulties.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
University Hospital Bordeaux
Bordeaux, 33000
University Hospital Clermont-Ferrand
Clermont-Ferrand, 63000
University Hospital Limoges
Limoges, 87000
University Hospital Marseille
Marseille, 13000
University Hospital Montpellier
Montpellier, 34000
University Hospital Nice
Nice, 06000
University HospitalToulouse
Toulouse, 31052
About this study
Official title: Dependence on Analgesics in Chronic Non-cancer Pain: Comparison of the Perceptions of the Algologist Physician and the Perception of the Patient.
The identification of an addiction to opioid analgesics has become strong recommendation for the purpose of improving the clinical management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself. The main objective of this study is to evaluate the factors associated to the discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception that the patient with non-cancer chronic pain has of this dependence.
Read the detailed description
The long-term use of opioid analgesics for the treatment of chronic non-cancer pain exposes patients to the risk of developing drug dependence on these psychoactive drugs with loss of control of their use. In general medicine as well as in algology consultation, the identification of an addiction to opioid analgesics (and even misuse as a gateway to addiction) have thus become strong recommendations for the purpose of improving the management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself.
The discrepancy between the assessment of drug dependence on analgesic drugs by the algologist and the perception that the patient has of this dependence will be investigated through a multicentre cross-sectional descriptive survey performed in pain treatment centres in France.
In addition to opioid analgesics, other pharmacological classes used for analgesic use will be investigated as they are concerned with the development of drug dependence. This is particularly the case for gabapentins.
- Conditions
- Pain, Chronic
- Being tested
- Questionnaire
- Keywords
- Analgesics
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
patient (self-questionnaire) and algologist physician (questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| Patients | data collection obtained from patient (self-questionnaire) and algologist physician (questionnaire). Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception of the patient
The patients will complete a self-questionnaire and the algologist physician will fill another questionnaire.
Measured: Baseline
Secondary outcomes (2)
Consumption drugs
Patient questionnaire for associated drug
Measured: Baseline
Anxiety
Hospital Anxiety and Depression Scale (HAD Scale)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start4 Nov 2017
- Primary completion19 Nov 2018
- Study completion18 Dec 2018
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 Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne ROUSSIN, PharmD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346408
- Sponsor's protocol ID
- RC31/17/0094
- Other IDs
- 2017-A01826-47
- Acronym
- DISCORDANCE
- Status last verified
- May 2024
- First submitted
- 10 Nov 2017
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roussin A, Cisse Z, Rousseau V, Roche G, Lestrade C, Cauchie A, Delage N, Donnet A, Van Obberghen E, Wood C, Lapeyre-Mestre M, Cantagrel N. Discordance between pain specialists and patients on the perception of dependence on pain medication: A multi-centre cross-sectional study. Therapie. 2024 Sep-Oct;79(5):543-551. doi: 10.1016/j.therap.2024.01.008. Epub 2024 Apr 12.
PubMed 38653623
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dependence on Analgesics in Chronic Non-cancer Pain: Comparison of the Perceptions of the Algologist Physician and the Perception of the Patient.
- ClinicalTrials.gov ID
- NCT03346408
- Acronym / sponsor ID
- DISCORDANCE / RC31/17/0094
- Conditions
- Pain, Chronic
- Keywords
- Analgesics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Nov 2017 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 17 Nov 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.
The identification of an addiction to opioid analgesics has become strong recommendation for the purpose of improving the clinical management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself. The main objective of this study is to evaluate the factors associated to the discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception that the patient with non-cancer chronic pain has of this dependence.
Detailed description
The long-term use of opioid analgesics for the treatment of chronic non-cancer pain exposes patients to the risk of developing drug dependence on these psychoactive drugs with loss of control of their use. In general medicine as well as in algology consultation, the identification of an addiction to opioid analgesics (and even misuse as a gateway to addiction) have thus become strong recommendations for the purpose of improving the management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself.
The discrepancy between the assessment of drug dependence on analgesic drugs by the algologist and the perception that the patient has of this dependence will be investigated through a multicentre cross-sectional descriptive survey performed in pain treatment centres in France.
In addition to opioid analgesics, other pharmacological classes used for analgesic use will be investigated as they are concerned with the development of drug dependence. This is particularly the case for gabapentins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: Questionnairedata collection obtained from patient (self-questionnaire) and algologist physician (questionnaire). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physician and patients recruited in pain consultations and treatment structures
Key inclusion criteria (2 listed)
- suffering from chronic non-cancer pain,
- taking at least one analgesic medication
Key exclusion criteria (4 listed)
- Patient minor or major protected by the law (under tutelage),
- Patient with chronic pain of cancerous origin,
- Opposition of the patient to be included in the study,
- Patient not having the overall skills to complete a self-questionnaire: major difficulties in understanding the French language and / or reading / writing difficulties.
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 |
|---|---|---|
| Questionnairepatient (self-questionnaire) and algologist physician (questionnaire) | Behavioural | Patients |
Primary outcome
discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception of the patient
Time frame: Baseline
The patients will complete a self-questionnaire and the algologist physician will fill another questionnaire.
2 secondary outcomes
Consumption drugs
Time frame: Baseline
Anxiety
Time frame: Baseline
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 30 May 2024.
- Results publication: PubMed 38653623Roussin A, Cisse Z, Rousseau V, Roche G, Lestrade C, Cauchie A, Delage N, Donnet A, Van Obberghen E, Wood C, Lapeyre-Mestre M, Cantagrel N. Discordance between pain specialists and patients on the perception of dependence on pain medication: A multi-centre cross-sectional study. Therapie. 2024 Sep-Oct;79(5):543-551. doi: 10.1016/j.therap.2024.01.008. Epub 2024 Apr 12.
- 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.
Anne ROUSSIN, PharmD PhD principal investigator
University Hospital, Toulouse
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic, run by University Hospital, Toulouse at 7 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 2 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception of the patient (time frame: Baseline). 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 NCT03346408, 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 30 May 2024.