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Use of Benzodiazepines and Z Drugs in the Elderly

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ClinicalTrials.gov Identifier: NCT01920581
Recruitment Status : Unknown
Verified August 2013 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : August 12, 2013
Last Update Posted : August 12, 2013
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease
Chronic Benzodiazepines and Related Drugs Users

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
Estimated Enrollment : 1100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Problematic Use of Benzodiazepines and Z Drugs in the Elderly in France: a Public Health Issue
Study Start Date : February 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Group/Cohort
volunteers



Primary Outcome Measures :
  1. Dependence according to DSM IV criteria [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. withdrawal syndrome [ Time Frame: 2 years ]
  2. psychiatric comorbidities [ Time Frame: 2 years ]
  3. Dependence scores [ Time Frame: 2 years ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920581


Contacts
Contact: Pascale Jolliet, PUPH 33 2.40.08.40.96 pascale.jolliet@chu-nantes.fr
Contact: Caroline Vigneau, PH 33 2.40.08.40.73 caroline.vigneau@chu-nantes.fr

Locations
France
CEIP Bordeaux Recruiting
Bordeaux, France
Contact: Haramburu, PH    0557571561    ceip.addictovigilance@pharmaco.u-bordeaux2.fr   
CEIP Caen Recruiting
Caen, France
Contact: Coquerel,, PUPH    0231064460    pharmacodependance@chu-caen.fr   
CEIP Grenoble Recruiting
Grenoble, France
Contact: Mallaret, PH    0476765145    pharmacodependance@chu-grenoble.fr   
CEIP Lille Recruiting
Lille, France
Contact: Bordet, PUPH    0320961818    pharmacodependance@chru-lille.fr   
CEIP Lyon Recruiting
Lyon, France
Contact: Descotes, PUPH    047216992    jacques-georges.descotes@chu-lyon.fr   
CEIP Marseille Recruiting
Marseille, France
Contact: Micallef, PH    0491745090    joelle.micallef@mail.ap-hm.fr   
CEIP Montpellier Recruiting
Montpellier, France
Contact: Peyrière, PH    0467336749,    pharmacodependance@chu-montpellier.fr   
CEIP Nancy Recruiting
Nancy, France
Contact: Kahn, PH    038385291    ceip@chu-nancy.fr   
CEIP Nantes Recruiting
Nantes, France
Contact: Pascale Jolliet, PUPH    02 40 08 40 96    pascale.jolliet@chu-nantes.fr   
CEIP Paris Recruiting
Paris, France
Contact: Djezzar, PH    0140054266    samira.djezzar@lrb.aphp.fr   
CEIP Toulouse Recruiting
Toulouse, France
Contact: Lapeyre-mestre, PH    0562260690    ceip.toulouse@cict.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Director: Pascale Jolliet, PUPH Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01920581     History of Changes
Other Study ID Numbers: BRD/10/06-W
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

Keywords provided by Nantes University Hospital:
CEIP
pharmacodependance
addictovigilance
benzodiazepines and benzodiazepines related drugs
elderly