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NCT03584542: ZORRO

ZOlpidem and the stRengthening of pRescription regulatiOn

Completed Last updated 4 January 2022
What this trial tests

trial testing No interventional study in Substance Use Disorders in 449 participants. Completed in 28 January 2020.

Timeline
25 July 2018
Primary endpoint
28 January 2020
28 January 2020

Quick facts

Lead sponsorNantes University Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment449
Start date25 July 2018
Primary completion28 January 2020
Estimated completion28 January 2020
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Substance Use Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Prevalence of zolpidem use in France halved after secure prescription pads implementation in 2017: A SNDS database nested cohort study.
    Caillet P, Rousselet M, Gerardin M, Jolliet P, et al · · 2020 · cited 14× · PMID 32074113 · DOI 10.1371/journal.pone.0228495
  2. 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.
    Gérardin M, Rousselet M, Caillet P, Grall-Bronnec M, et al · · 2019 · cited 14× · PMID 31256026 · DOI 10.1136/bmjopen-2018-027443
  3. Perception of the Regulatory Change for Zolpidem Prescription by French General Practitioners and Its Relation to Prescription Behavior.
    Laforgue EJ, Istvan M, Schreck B, Mainguy M, et al · · 2022 · cited 5× · PMID 35456269 · DOI 10.3390/jcm11082176
  4. 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.
    Istvan M, Rousselet M, Laforgue EJ, Guerlais M, et al · · 2022 · cited 2× · PMID 35255750 · DOI 10.1080/14740338.2022.2047930
  5. Regulatory Framework Implementation for the Prescription of Zolpidem in France, What Impact in the Older People?
    Jobert A, Istvan M, Laforgue EJ, Schreck B, et al · · 2021 · cited 2× · PMID 34831853 · DOI 10.3390/ijerph182212099
  6. Did the New French Regulation of Zolpidem Decrease the Problematic Consumption of Zolpidem? A Field Study among Users.
    Laforgue EJ, Rousselet M, Claudon A, Aquizerate A, et al · · 2022 · PMID 35897285 · DOI 10.3390/ijerph19158920

Verify or expand the search:

Other trials of No interventional study

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Other Nantes University Hospital trials

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