Dependence on Analgesics in Chronic Non-cancer Pain | NCT03346408

Studies
Dependence on Analgesics in Chronic Non-cancer Pain

NCT03346408

Sponsor

University Hospital, Toulouse

Status

Completed

Last Update Posted

May 30, 2024Actual

Enrollment

220Actual

Phase

Not provided

Conditions

Pain, Chronic

Interventions

Questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-A01826-47	Other Identifier	IDRCB

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2017Actual

Primary Completion Date

Nov 19, 2018Actual

Completion Date

Dec 18, 2018Actual

First Submitted Date

Nov 10, 2017

First Submission Date that Met QC Criteria

Nov 14, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2024

Last Update Posted Date

May 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		data collection obtained from patient (self-questionnaire) and algologist physician (questionnaire).	Behavioral: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Behavioral	patient (self-questionnaire) and algologist physician (questionnaire)	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Consumption drugs	Patient questionnaire for associated drug	Baseline
Anxiety	Hospital Anxiety and Depression Scale (HAD Scale)	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Physician and patients recruited in pain consultations and treatment structures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne ROUSSIN, PharmD PhD	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Bordeaux		Bordeaux		33000	France
University Hospital Clermont-Ferrand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38653623	Result	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.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms