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Dependence on Analgesics in Chronic Non-cancer Pain (DISCORDANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03346408
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment
Pain, Chronic Behavioral: Questionnaire

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
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Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dependence on Analgesics in Chronic Non-cancer Pain: Comparison of the Perceptions of the Algologist Physician and the Perception of the Patient.
Actual Study Start Date : November 4, 2017
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : December 18, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients
data collection obtained from patient (self-questionnaire) and algologist physician (questionnaire).
 Behavioral: Questionnaire
patient (self-questionnaire) and algologist physician (questionnaire)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Consumption drugs [ Time Frame: Baseline ]
    Patient questionnaire for associated drug

  2. Anxiety [ Time Frame: Baseline ]
    Hospital Anxiety and Depression Scale (HAD Scale)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Physician and patients recruited in pain consultations and treatment structures
Criteria

Inclusion Criteria:

  • suffering from chronic non-cancer pain,
  • taking at least one analgesic medication

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346408


Locations
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France
University Hospital Bordeaux
Bordeaux, France, 33000
University Hospital Clermont-Ferrand
Clermont-Ferrand, France, 63000
University Hospital Limoges
Limoges, France, 87000
University Hospital Marseille
Marseille, France, 13000
University Hospital Montpellier
Montpellier, France, 34000
University Hospital Nice
Nice, France, 06000
University HospitalToulouse
Toulouse, France, 31052
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Anne ROUSSIN, PharmD PhD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03346408    
Other Study ID Numbers: RC31/17/0094
2017-A01826-47 ( Other Identifier: IDRCB )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Analgesics
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations