Substance Use Disorders Clinical Trial
— ZORROOfficial title:
Impact of Regulatory Framework Change for Zolpidem Prescriptions (Secure Prescription) on Consumption and Misuse of Sedatives Drugs.
NCT number | NCT03584542 |
Other study ID # | RC17_0381 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 25, 2018 |
Est. completion date | January 28, 2020 |
Verified date | January 2022 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 449 |
Est. completion date | January 28, 2020 |
Est. primary completion date | January 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Nantes University Hospital | Nantes | Loire-Atlantique |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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