AddictionsCOSMOSNCT02849574
Evaluation of Changes in Consumption of Drugs and Substances After Incarceration
An observational study of Addictions, run by Nantes University Hospital at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addictions
- How many people
- 629 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Major subject
- Subject in the fourth or fifth month of incarceration
- Held about agreeing to participate in the study
Who cannot join
- Patient refusing to participate
- Patient unable to respond to the questionnaire (major difficulties understanding of the French language)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Angers University Hospital
Angers, 49000
Fontenay Le Comte Hospital
Fontenay-le-Comte, 85200
La Roche sur Yon Hospital
La Roche-sur-Yon, 85000
Laval Hospital
Laval, 53000
Le Mans Hospital
Le Mans, 72000
Nantes University Hospital
Nantes, 44093
About this study
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.
- Conditions
- Addictions
- Medical subject headings
- Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
change in practices of consumption of psychoactive substances between the period prior to incarceration and detention period
composite endpoint representing the existence of a change in practices of consumption of psychoactive substances between the period prior to incarceration and detention period
Measured: Until 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline VICTORRI-VIGNEAU, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849574
- Sponsor's protocol ID
- RC14_0259
- Acronym
- COSMOS
- Status last verified
- Jul 2016
- First submitted
- 27 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Consumption of Drugs and Substances After Incarceration
- ClinicalTrials.gov ID
- NCT02849574
- Acronym / sponsor ID
- COSMOS / RC14_0259
- Conditions
- Addictions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Major subject
- Subject in the fourth or fifth month of incarceration
- Held about agreeing to participate in the study
Key exclusion criteria (2 listed)
- Patient refusing to participate
- Patient unable to respond to the questionnaire (major difficulties understanding of the French language)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline VICTORRI-VIGNEAU, Dr principal investigator
Nantes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addictions, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in practices of consumption of psychoactive substances between the period prior to incarceration and detention period (time frame: Until 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.