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ZOlpidem and the stRengthening of pRescription regulatiOn (ZORRO)

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ClinicalTrials.gov Identifier: NCT03584542
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
For several years, the French Addictovigilance Network (FAN) highlights potential problematic consumptions with zolpidem. To prevent abuse and misuse of zolpidem, the French Health Products Agency has changed the regulatory framework of zolpidem prescription. Thus, since the 10th of April 2017 zolpidem prescriptions have to be secured (particular support, dosage written out). The investigators hypothesized that this change will affect zolpidem consumption but also the consumption of all sedative drugs. In order to assess the incidence of the regulatory change for zolpidem prescription the investigators conduct a two part study: an epidemiological study with French National Health Insurance Fund for Employees database and an observational study with general practitioners and zolpidem consumers.

Condition or disease Intervention/treatment
Substance Use Disorders Other: No interventional study

Detailed Description:

Several aspects of the incidence will be assessed (number of zolpidem consumers, change in consumption profile, and consumption of other sedative drugs) before and after the regulatory framework change.

The epidemiological study will enable us to respond to all these aspects and it will be completed by the observational study with practitioners and patients that have been affected by the regulatory framework change.

General practitioners will be interviewed by phone about their perception of the regulatory framework change, their attitudes towards their patients with zolpidem prescription and the drugs they used if they had changed the patients prescription.

All consumers included in the study will have to fulfill a self-questionnaire about their perception of the regulatory framework change, their attitudes towards their consumption of zolpidem (stop, diminution, replacement) and their favorite replacement drug.

The impact of regulatory prescription change of zolpidem will have a pleiotropic impact which can't be evaluated on a single criterion. It must be considered in a global, multifocal manner. This is why several criteria will be used to assess several incidence and several populations.

These different approaches will enable us to respond to three questions

  • What is the impact on the number of consumers? Prevalence and incidence of zolpidem consumers over several periods (before and after the regulatory prescription change) will be evaluated from French National Health Insurance Fund for Employees database.
  • What is the impact on consumption patterns of zolpidem? The investigators will assess different patterns of zolpidem consumption (i) occasional use versus chronic use will be assessed from French National Health Insurance Fund for Employees database and from consumers of general medicine and specialized centers for drug addict patients (ii) problematic use (consumption not in accordance with summary of product characteristics according to at least one of these parameters: duration of consumption, dosage, manner in which zolpidem is obtained, route of administration, or seeking psychoactive effects different from hypnotic effect) versus no problematic use will be assessed from French National Health Insurance Fund for Employees database and from consumers of general medicine and specialized centers for drug addict patients.
  • What is the impact on consumption of other sedatives drugs? The investigators will look for reports of zolpidem prescriptions on other drugs and if reports are maintained from French National Health Insurance Fund for Employees database, general practitioners will be interviewed about change in their prescriptions and their preferred drug for replacement, and consumers of general medicine and specialized centers for drug addict patients will be asked about their attitudes towards their consumption of zolpidem (stop, diminution, replacement) and their favorite replacement drug.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Impact of Regulatory Framework Change for Zolpidem Prescriptions (Secure Prescription) on Consumption and Misuse of Sedatives Drugs.
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients in general practitioners' offices
No interventional study. Only one questionnaire will be done
Other: No interventional study
No Interventional study - Only one questionnaire will be done for patients and for general practitioners

Patients of specialized centers for drug addict patients
No interventional study Only one questionnaire will be done
Other: No interventional study
No Interventional study - Only one questionnaire will be done for patients and for general practitioners

General practitioners
No interventional study Only one questionnaire will be done
Other: No interventional study
No Interventional study - Only one questionnaire will be done for patients and for general practitioners




Primary Outcome Measures :
  1. Prevalence of zolpidem consumers and substance use disorders with zolpidem (according to the number of DSM 5 criteria) before and after the regulatory prescription change [ Time Frame: Day 1 ]

    The impact of regulatory prescription change of zolpidem will have a pleiotropic impact which can't be evaluated on a single criterion. It must be considered in a global, multifocal manner. This is why several criteria will be used to assess several incidence and several populations.

    These different approaches will enable us to respond to three questions

    • What is the impact on the number of consumers?
    • What is the impact on consumption patterns of zolpidem?
    • What is the impact on consumtion of other sedative drugs? Cf "detailed desciption" paragraph



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

For the epidemiological study: all the patients of the database between January 2016 and December 2018 will be selected.

For the observational study with general practitioners: 100. For the observational study with zolpidem consumers from general medicine and specialized centers for drug addict patients: 400 (200 from general medicine and 200 from specialized centres).

Criteria

Inclusion Criteria:

Epidemiological study: all the patients of the database between January 2016 and December 2018 will be selected.

Observational study with general practitioners:

  • General practitioners drawn by the sampling methodology or general practitioners that are habitual partners of the investigator service.
  • General practitioners located in liberal cabinet when the change in regulatory framework has been applied.
  • General practitioners who accept the interview.

Observational study with zolpidem consumers:

  • Being a patient from one of the general practitioners participating in the study or going in one of the specialized centers for drug addict patients participating in the study.
  • Having a problematic consumption of zolpidem when the regulatory framework change was applied according to the general practitioner or to the specialized centre staff.
  • Giving consent oral to participate.

Exclusion Criteria:

Epidemiological study: none

Observational study with general practitioners:

- General practitioners who not respond to the phone call after several attempts.

Observational study with zolpidem consumers:

  • being under 18 years of age
  • being an adult protected
  • having difficulties to understand, read or write French language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584542


Contacts
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Contact: Caroline VICTORRI-VIGNEAU, Dr 02 40 08 40 73 caroline.vigneau@chu-nantes.fr
Contact: Morgane ROUSSELET morgane.rousselet@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03584542     History of Changes
Other Study ID Numbers: RC17_0381
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Zolpidem
hypnotics and sedatives
Drug and narcotic control
Drug prescription
Substance-related Disorders
Health Impact Assessment
Additional relevant MeSH terms:
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Zolpidem
Central Nervous System Depressants
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action