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Divided Drug Delivery (DEFIMED-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02869724
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : August 17, 2016
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
This study will evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated.

Condition or disease Intervention/treatment Phase
Hospitalized for Voluntary Drug Intoxication Other: Weekly divided delivery Other: Monthly divided delivery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Divided Drug Delivery : a Way to Prevent Repeated Volutary Drug Intoxications.
Study Start Date : March 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arm Intervention/treatment
Active Comparator: Weekly divided delivery
Hospitalized for voluntary drug intoxications.
Other: Weekly divided delivery
Active Comparator: Monthly divided delivery
Hospitalized for voluntary drug intoxications.
Other: Monthly divided delivery



Primary Outcome Measures :
  1. Evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated [ Time Frame: 6 months ]
    Number of cumulative voluntary drug intoxications throughout the 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women between 18 and 65 years.
  • Hospitalized after a voluntary drug intoxication.
  • History of two voluntary drug intoxications at least.
  • Person registered for social security.
  • Signed free consent.

Exclusion Criteria:

  • Patients under treatment for opiate split
  • Acute or chronicgoing wild.
  • Cognitive problems hindering understanding of questionnaires
  • Persons targeted by articles L1121-5 to L1121-8 of CSP

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): NCT02869724


Contacts
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Contact: Maurice Dematteis, Professor +66236 MDematteis@chu-grenoble.fr
Contact: Michel Mallaret, Doctor 04 76 76 41 55 mmallaret@chu-grenoble.fr

Locations
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France
UniversityHospitalGrenoble Recruiting
La Tronche, France, 38700
Contact: Maurice Dematteis, Professor    +66236    MDematteis@chu-grenoble.fr   
Contact: Michel Mallaret, Doctor    04 76 76 41 55    mmallaret@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Maurice Dematteis, Professor Grenoble Hospital University
Additional Information:
Publications:
Aouba, A., Péquignot, F., Camelin, L., Laurent, F., Jougla, E. La mortalité par suicide en France en 2006. Etudes et résultats. 2009 ; (702) : 1-8.
Beck, F., Guignard, R., Du Roscoät, E., Saïas, T. Tentatives de suicide et pensées suicidaires en France en 2010. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 488-492.
Chan-Chee, C., & Jezewski-Serra, D. Hospitalisations pour tentatives de suicide entre 2004 et 2007 en France métropolitaine. Analyse du PMSI-MCO. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 492-496.
Dumesnil, S., Grandfils, N., Le Fur, P., Mizrahi, A. Mizrahi, A. Santé, Soins et protection Sociale en France en 1996. CREDES (en ligne). Novembre 1997, (consulté le 3/4/12).
Fournet, N., Caillère, N., Fouillet, A., Caserio-Schönemann, C., Josseran, L. Le système français de surveillance sanitaire des urgences et des décès (Sur-SaUD®). Saint-Maurice : Institut de veille sanitaire : 2011. 12p.
Mateos Rodríguez, A.A, Huerta Arroyo, A., Benito Vellisca, M.A. The epidemiology of suicide attempts using drugs. Emergencias. 2007 ; 19 : 251-254.
Michel, G., Aquaviva, E., Aubron, V., Purper-ouakil, D. Suicides : mieux comprendre, pour prévenir avec plus d'efficacité. In : Beck F, Guilbert P, Gautier A (dir). Baromètre santé 2005. Saint-Denis : Inpes. 2007 ; 487-506.
Mouquet, M.C., & Bellamy, V. Suicides et tentatives de suicide en France. Etudes et Résutlats. 2006 ; 488 :1-8.
Rodríguez, A.A.M., Arroyo, A.H., and Vellisca, M.A.B. (2007). The epidemiology of suicide attempts using drugs. Emergencias. 2007 ; 19 : 251-254.
Saviuc, P., Bedry, R., Flesch, F. Epidémiologie des intoxications médicamenteuses volontaires. Médecine Thérapeutique. 1999; 5(1): 45-8.
Theil, F. Evolution qualitative des médicaments incriminés dans les intoxications médicamenteuses sur une période de 10 ans. Créteil (Paris XII). 64 pages. 2007. (Thèse de médecine).

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02869724    
Other Study ID Numbers: 38RC13.577
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Grenoble:
IMV : voluntary drug intoxications
Drug
Divided prescription
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders