- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02849574
Evaluation of Changes in Consumption of Drugs and Substances After Incarceration (COSMOS)
July 28, 2016 updated by: Nantes University Hospital
To improve the management and risk reduction, it is essential to understand the evolution of the consumption of psychoactive substances, medicated or not in detention; it does not have at present no data on this subject.
This work has as main objective to evaluate the development of substance use terms (goods and consumption practices) by the inmates between the period preceding their incarceration and their fifth month in detention.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
629
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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Angers, France, 49000
- Angers University Hospital
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Fontenay Le Comte, France, 85200
- Fontenay Le Comte Hospital
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La Roche sur Yon, France, 85000
- La Roche Sur Yon Hospital
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Laval, France, 53000
- Laval Hospital
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Le Mans, France, 72000
- Le Mans Hospital
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Nantes, France, 44093
- Nantes University Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The eligible study population is incarcerated major subjects.
The topics will be selected subjects incarcerated in remand centers participating in the study.
All subjects were medical examination, Home Maintenance arriving at their entrance into custody.
On this occasion, the medical staff will verify the absence of non inclusion criterion and the subject will be informed orally and via an information sheet that will retain an invitation to respond to an anonymous questionnaire will be sent after him 4 or 5 months of detention (as prisons).
He may accept or reject this invitation.
Description
Inclusion Criteria:
- Major subject
- Subject in the fourth or fifth month of incarceration
- Held about agreeing to participate in the study
Exclusion Criteria:
- Patient refusing to participate
- Patient unable to respond to the questionnaire (major difficulties understanding of the French language)
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 |
Measure Description |
Time Frame |
|---|---|---|
|
change in practices of consumption of psychoactive substances between the period prior to incarceration and detention period
Time Frame: Until 5 months
|
composite endpoint representing the existence of a change in practices of consumption of psychoactive substances between the period prior to incarceration and detention period
|
Until 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Caroline VICTORRI-VIGNEAU, Dr, Nantes University Hospital
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, 2015
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
July 27, 2016
First Submitted That Met QC Criteria
July 28, 2016
First Posted (Estimate)
July 29, 2016
Study Record Updates
Last Update Posted (Estimate)
July 29, 2016
Last Update Submitted That Met QC Criteria
July 28, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC14_0259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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