- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02245685
Longitudinal 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
July 18, 2017 updated by: Nantes University Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
113
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
-
-
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Saint-Nazaire, France, 44600
- CSST "La Rose des Vents"
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients under substitution therapy monitored in a specialized care center for addicts
Description
Inclusion Criteria:
- Patients entering a specialized medical care center for addicts
Exclusion Criteria:
- Patients refusing to sign the consent for participation
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evolution of the severity score to heroin addiction (TMSP score)
Time Frame: 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)
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evolution of the score of quality of life scale
Time Frame: 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)
|
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)
|
Evolution of the severity score to heroin addiction (TMSP score)
Time Frame: From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
|
From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
|
Evolution of the score of quality of life scale
Time Frame: From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
|
From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pascale JOLLIET, MD, 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.
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
January 1, 2008
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 15, 2014
First Submitted That Met QC Criteria
September 17, 2014
First Posted (Estimate)
September 19, 2014
Study Record Updates
Last Update Posted (Actual)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 18, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRD/07/07-M
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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