ZOlpidem and the stRengthening of pRescription regulatiOn

NCT03584542 | Completed

• 1 other identifier: RC17_0381
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders

Keywords

Zolpidem; hypnotics and sedatives; Drug and narcotic control; Drug prescription; Substance-related Disorders; Health Impact Assessment

Outcome Measures

Primary Outcomes (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

  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

  Day 1

Study Arms (3)

Patients in general practitioners' offices

No interventional study. Only one questionnaire will be done

Other: No interventional study

Patients of specialized centers for drug addict patients

No interventional study Only one questionnaire will be done

Other: No interventional study

General practitioners

No interventional study Only one questionnaire will be done

Other: No interventional study

Interventions

No interventional study OTHER

No Interventional study - Only one questionnaire will be done for patients and for general practitioners

General practitioners; Patients in general practitioners' offices; Patients of specialized centers for drug addict patients

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

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Related Publications (2)

• Istvan M, Rousselet M, Laforgue EJ, Guerlais M, Gerardin M, Jolliet P, Feuillet F, Victorri-Vigneau C. Did the pattern of use of zolpidem change since the enforcement of a new prescription rule? A latent class analysis using the French health insurance database. Expert Opin Drug Saf. 2022 Sep;21(9):1225-1234. doi: 10.1080/14740338.2022.2047930. Epub 2022 Mar 8.

  PMID: 35255750 DERIVED

• Gerardin M, Rousselet M, Caillet P, Grall-Bronnec M, Loue P, Jolliet P, Victorri-Vigneau C. French national health insurance database analysis and field study focusing on the impact of secure prescription pads on zolpidem consumption and sedative drug misuse: ZORRO study protocol. BMJ Open. 2019 Jun 28;9(6):e027443. doi: 10.1136/bmjopen-2018-027443.

  PMID: 31256026 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 12, 2018
• Study Start: July 25, 2018
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: January 4, 2022

Record last verified: 2022-01

Locations

FR (1)