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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02245685
Other study ID # BRD/07/07-M
Secondary ID
Status Completed
Phase N/A
First received September 15, 2014
Last updated July 18, 2017
Start date January 2008
Est. completion date June 2014

Study information

Verified date July 2017
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of the plan underlines the need to improve practices and access to opioid substitution treatment. Priority 3 stresses the importance of articulation and coordination between specialized structures and community medicine to optimize the quality of care and to ensure continuity in the followup of these patients. This study focuses on the followup of patients under substitution therapy from the moment they enter a specialized care center for addicts to the period they are monitored by a general practitioner outside the specialized care center. The assessment described in this study should allow to harmonize and keep a continuity in patient monitoring.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients entering a specialized medical care center for addicts

Exclusion Criteria:

- Patients refusing to sign the consent for participation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CSST "La Rose des Vents" Saint-Nazaire

Sponsors (2)

Lead Sponsor Collaborator
Nantes University Hospital French Health Products Safety Agency

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of the severity score to heroin addiction (TMSP score) From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years)
Secondary Evolution of the score of quality of life scale From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years)
Secondary Evolution of the severity score to heroin addiction (TMSP score) From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
Secondary Evolution of the score of quality of life scale From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
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