Substance Use DisordersZORRONCT03584542
ZOlpidem and the stRengthening of pRescription regulatiOn
An observational study of Substance Use Disorders, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- How many people
- 449 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2018to 28 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Regulatory Framework Change for Zolpidem Prescriptions (Secure Prescription) on Consumption and Misuse of Sedatives Drugs.
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- No interventional study
- Keywords
- Zolpidem, hypnotics and sedatives, Drug and narcotic control, Drug prescription, Substance-related Disorders, Health Impact Assessment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventional studyOther
No Interventional study - Only one questionnaire will be done for patients and for general practitioners
| Study group | Role | What they receive |
|---|---|---|
| Patients in general practitioners' offices | No interventional study. Only one questionnaire will be done Receives: Other: No interventional study | |
| Patients of specialized centers for drug addict patients | No interventional study Only one questionnaire will be done Receives: Other: No interventional study | |
| General practitioners | No interventional study Only one questionnaire will be done Receives: Other: No interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start25 Jul 2018
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584542
- Sponsor's protocol ID
- RC17_0381
- Acronym
- ZORRO
- Status last verified
- Jan 2022
- First submitted
- 12 Jun 2018
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35255750Gerardin 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.
PubMed 31256026
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regulatory Framework Change for Zolpidem Prescriptions (Secure Prescription) on Consumption and Misuse of Sedatives Drugs.
- ClinicalTrials.gov ID
- NCT03584542
- Acronym / sponsor ID
- ZORRO / RC17_0381
- Conditions
- Substance Use Disorders
- Keywords
- Zolpidem, hypnotics and sedatives, Drug and narcotic control, Drug prescription, Substance-related Disorders, Health Impact Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients in general practitioners' offices | – | Other: No interventional studyNo interventional study. Only one questionnaire will be done |
| Patients of specialized centers for drug addict patients | – | Other: No interventional studyNo interventional study Only one questionnaire will be done |
| General practitioners | – | Other: No interventional studyNo interventional study Only one questionnaire will be done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- Epidemiological study: all the patients of the database between January 2016 and December 2018 will be selected.
- 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.
- 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.
Key exclusion criteria (7 listed)
- Epidemiological study: none
- General practitioners who not respond to the phone call after several attempts.
- being under 18 years of age
- being an adult protected
- having difficulties to understand, read or write French language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventional studyNo Interventional study - Only one questionnaire will be done for patients and for general practitioners | Other | General practitioners, Patients in general practitioners' offices, Patients of specialized centers for drug addict patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 35255750Istvan 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.
- Derived from this study: PubMed 31256026Gerardin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584542, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.