Use of Benzodiazepines and Z Drugs in the Elderly

August 9, 2013 updated by: Nantes University Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dependence according to DSM IV criteria
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
withdrawal syndrome
Time Frame: 2 years
2 years
psychiatric comorbidities
Time Frame: 2 years
2 years
Dependence scores
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Study Director: Pascale Jolliet, PUPH, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 9, 2013

First Posted (Estimate)

August 12, 2013

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BRD/10/06-W

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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