Chronic Benzodiazepines and Related Drugs UsersNCT01920581
Use of Benzodiazepines and Z Drugs in the Elderly
An observational study of Chronic Benzodiazepines and Related Drugs Users, run by Nantes University Hospital at 11 sites in France.
Trial summary
The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and zopiclone) usage in an outpatient population of chronic users over 65 years in France using a questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical Manual of mental disorders) international… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Benzodiazepines and Related Drugs Users
- How many people
- 1,100 participants
- Where
- 11 sitesFrance
- Study dates
- Feb 2012to Feb 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 65 years old or more volunteers,with benzodiazepines or benzodiazepines related drugs treatment for at least three months, written consent and without exclusion criteria.
Who may be able to join
- 65 years old or more,
- benzodiazepines or benzodiazepines related drugs treatment for at least three months,
- written consent and without exclusion criteria.
Who cannot join
- no written consent form
- difficulties to understand or speak french
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CEIP Bordeaux
Bordeaux
Haramburu, PH, 0557571561, ceip.addictovigilance@pharmaco.u-bordeaux2.fr
- Recruiting
CEIP Caen
Caen
Coquerel,, PUPH, 0231064460, pharmacodependance@chu-caen.fr
- Recruiting
CEIP Grenoble
Grenoble
Mallaret, PH, 0476765145, pharmacodependance@chu-grenoble.fr
- Recruiting
CEIP Lille
Lille
Bordet, PUPH, 0320961818, pharmacodependance@chru-lille.fr
- Recruiting
CEIP Lyon
Lyon
Descotes, PUPH, 047216992, jacques-georges.descotes@chu-lyon.fr
- Recruiting
CEIP Marseille
Marseille
Micallef, PH, 0491745090, joelle.micallef@mail.ap-hm.fr
- Recruiting
CEIP Montpellier
Montpellier
Peyrière, PH, 0467336749,, pharmacodependance@chu-montpellier.fr
- Recruiting
CEIP Nancy
Nancy
Kahn, PH, 038385291, ceip@chu-nancy.fr
- Recruiting
CEIP Nantes
Nantes
Pascale Jolliet, PUPH, 02 40 08 40 96, pascale.jolliet@chu-nantes.fr
- Recruiting
CEIP Paris
Paris
Djezzar, PH, 0140054266, samira.djezzar@lrb.aphp.fr
- Recruiting
CEIP Toulouse
Toulouse
Lapeyre-mestre, PH, 0562260690, ceip.toulouse@cict.fr
About this study
Official title: Assessment of Problematic Use of Benzodiazepines and Z Drugs in the Elderly in France: a Public Health Issue
The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and zopiclone) usage in an outpatient population of chronic users over 65 years in France using a questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical Manual of mental disorders) international standards.
Read the detailed description
1100 patients will be recruited by pharmacists. They will answer to a standardized questionnaire assessing their benzodiazepines or related drugs usage (phone contact).
Pharmacists are recruited by all French Centers For Evaluation and Information on Pharmacodependence (CEIP).
- Keywords
- CEIP, pharmacodependance, addictovigilance, benzodiazepines and benzodiazepines related drugs, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependence according to DSM IV criteria
Measured: 2 years
Secondary outcomes (3)
withdrawal syndrome
Measured: 2 years
psychiatric comorbidities
Measured: 2 years
Dependence scores
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Benzodiazepines and Related Drugs UsersStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Jolliet, PUPH, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920581
- Sponsor's protocol ID
- BRD/10/06-W
- Status last verified
- Aug 2013
- First submitted
- 8 Aug 2013
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Victorri-Vigneau C, Laforgue EJ, Grall-Bronnec M, Guillou-Landreat M, Rousselet M, Guerlais M; FAN-Network; Feuillet F, Jolliet P. Are Seniors Dependent on Benzodiazepines? A National Clinical Survey of Substance Use Disorder. Clin Pharmacol Ther. 2021 Feb;109(2):528-535. doi: 10.1002/cpt.2025. Epub 2020 Sep 23.
PubMed 32860424
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Problematic Use of Benzodiazepines and Z Drugs in the Elderly in France: a Public Health Issue
- ClinicalTrials.gov ID
- NCT01920581
- Acronym / sponsor ID
- BRD/10/06-W
- Keywords
- CEIP, pharmacodependance, addictovigilance, benzodiazepines and benzodiazepines related drugs, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 12 Aug 2013 (estimated)
- 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.
The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and zopiclone) usage in an outpatient population of chronic users over 65 years in France using a questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical Manual of mental disorders) international standards.
Detailed description
1100 patients will be recruited by pharmacists. They will answer to a standardized questionnaire assessing their benzodiazepines or related drugs usage (phone contact).
Pharmacists are recruited by all French Centers For Evaluation and Information on Pharmacodependence (CEIP).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 65 years old or more volunteers,with benzodiazepines or benzodiazepines related drugs treatment for at least three months, written consent and without exclusion criteria.
Key inclusion criteria (3 listed)
- 65 years old or more,
- benzodiazepines or benzodiazepines related drugs treatment for at least three months,
- written consent and without exclusion criteria.
Key exclusion criteria (2 listed)
- no written consent form
- difficulties to understand or speak french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dependence according to DSM IV criteria
Time frame: 2 years
3 secondary outcomes
withdrawal syndrome
Time frame: 2 years
psychiatric comorbidities
Time frame: 2 years
Dependence scores
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Derived from this study: PubMed 32860424Victorri-Vigneau C, Laforgue EJ, Grall-Bronnec M, Guillou-Landreat M, Rousselet M, Guerlais M; FAN-Network; Feuillet F, Jolliet P. Are Seniors Dependent on Benzodiazepines? A National Clinical Survey of Substance Use Disorder. Clin Pharmacol Ther. 2021 Feb;109(2):528-535. doi: 10.1002/cpt.2025. Epub 2020 Sep 23.
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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.
Pascale Jolliet, PUPH study director
Nantes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Benzodiazepines and Related Drugs Users, run by Nantes University Hospital at 11 sites 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascale Jolliet, PUPH (33 2.40.08.40.96, pascale.jolliet@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dependence according to DSM IV criteria (time frame: 2 years). 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 NCT01920581, which also lists 1 linked publication.
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 12 Aug 2013.