Evaluation of an Opioid Decrease Strategy in Chronic (EODSCPP)

Evaluation of an Opioid Decrease Strategy in Chronic Pain Patients at the Pain Assessment and Treatment Center in Montpellier: Prospective Study Over 6 Months.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: opioid withdrawal

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).

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion criteria:

• chronic pain patient
• major
• supported at CETD

Exclusion criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the dosage of opioid and co-analgesic treatments	Change of the dosage of opioid and co-analgesic treatments	3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring quality of life	interview with the patient	Inclusion, 3 and 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Théa GENDARME, MD, PharmD, MSc, UH Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Opioid analgesics; Opioid use disorders; Prescription drug abuse; treatments Prevention Identification
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: RECHMPL20_0132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No