Evaluation of an Opioid Decrease Strategy in Chronic

Chronic Pain Clinical Trial

— EODSCPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424459
• Other study ID #: RECHMPL20_0132
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 30, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• chronic pain patient

• major

• supported at CETD

Exclusion criteria:

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measuring quality of life	interview with the patient	Inclusion, 3 and 6 months