Evaluation of an Opioid Decrease Strategy in Chronic

NCT ID: NCT04424459

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-07-30

Brief Summary

Increase in the consumption of analgesics observed in many countries with a mediatic crisis resulting in an increasingly frequent wish of patients to wean themselves from opiates. A recent update (B. Rolland 2017) suggests that upon initiation of an opioid analgesic treatment, the patient should be informed of the risk of opioid dependence and misuse. There is no clearly validated decay scheme in the event of dependence in patients with Chronic Non-Cancer Pain.

Hypotheses:

• Possibility of a rapid decrease in opioid analgesic treatments at DCNC sensitized to the risk of DOP and MOP. (Protocol implemented: Multidisciplinary assessment, workshops and information sheet on chronic pain, treatments and risk of DOP, pharmacological and nonpharmacological adaptation)
• Highlight the need for additional information from patients and prescribers on the risk of DOP and MOP in DCNC.

Detailed Description

Main objective: Check if the rapid to semi-rapid regimen (- 25 to -60% dosage in 5 days of HDS) of opioid analgesics, without the use of methadone or buprenorphine agonists, in the case of DCNC at the CETD in Montpellier is efficient in the medium term (6 months).

Secondary objective:

• With our inclusion questionnaire we wanted to check if the patients had been made aware of the risk of opiate dependence and misuse.
• Detect the conditions of prescriptions that can promote the misuse of opiates.
• Evaluating the different components of residual pain at 6 months (type, intensity, anxiety component and depression, function).

Conditions

Chronic Pain

Keywords

Opioid analgesics; Opioid use disorders; Prescription drug abuse; treatments Prevention Identification

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients included from 10/01/19 to 12/31/19.

Patients included from 10/01/19 to 12/31/19. (the study will be extended to a larger number of patients according to the first results), continued according to the first results. DCNC patients treated at the Montpellier Pain Assessment and Treatment Center hospitalized during the period from 10/01/19 to 12/31/19, for misuse of opioid treatment.

opioid withdrawal

Intervention Type: DRUG

The data retrieved from the patient will be encrypted and there will also be written data or written in binary form. They will be used to create an Excel table which allows me to list the data on D1 then on M + 3 then on M + 6 in order to evaluate the evolution of these data over a time interval of 6 months and this is which will be used as support in my thesis in pharmacy.

Interventions

opioid withdrawal

The data retrieved from the patient will be encrypted and there will also be written data or written in binary form. They will be used to create an Excel table which allows me to list the data on D1 then on M + 3 then on M + 6 in order to evaluate the evolution of these data over a time interval of 6 months and this is which will be used as support in my thesis in pharmacy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• chronic pain patient
• major
• supported at CETD

Exclusion Criteria

-patient with physical and mental incapacity to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Théa GENDARME, MD, PharmD, MSc

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL20_0132

Identifier Type: -

Identifier Source: org_study_id