Use of Benzodiazepines and Z Drugs in the Elderly | NCT01920581

Studies
Use of Benzodiazepines and Z Drugs in the Elderly

NCT01920581

Sponsor

Nantes University Hospital

Status

Unknown status

Last Update Posted

Aug 12, 2013Estimated

Enrollment

1,100Estimated

Phase

Not provided

Conditions

Chronic Benzodiazepines and Related Drugs Users

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Feb 2014Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Aug 8, 2013

First Submission Date that Met QC Criteria

Aug 9, 2013

First Posted Date

Aug 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2013

Last Update Posted Date

Aug 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,100Estimated

Label	Type	Description	Intervention Names
volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dependence according to DSM IV criteria		2 years

Secondary Outcomes

Measure	Description	Time Frame
withdrawal syndrome		2 years
psychiatric comorbidities		2 years
Dependence scores

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 years old or more,
benzodiazepines or benzodiazepines related drugs treatment for at least three months,
written consent and without exclusion criteria.

Exclusion Criteria:

no written consent form
difficulties to understand or speak french

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pascale Jolliet, PUPH	Contact	33 2.40.08.40.96		pascale.jolliet@chu-nantes.fr
Caroline Vigneau, PH	Contact	33 2.40.08.40.73		caroline.vigneau@chu-nantes.fr

Overall Officials

Name	Affiliation	Role
Pascale Jolliet, PUPH	Nantes University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CEIP Bordeaux	Recruiting	Bordeaux			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32860424	Derived	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.