Evaluation of an Opioid Decrease Strategy in Chronic

NCT04424459 | Completed

• 1 other identifier: RECHMPL20_0132
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measuring quality of life

  Inclusion, 3 and 6 months

Study Arms (1)

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

Interventions

opioid withdrawal 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• chronic pain patient
• major
• supported at CETD

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Théa GENDARME, MD, PharmD, MSc

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 11, 2020
• Study Start: October 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 30, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)