People IncarceratedNCT04380714
Changes in the Consumption of Psychoactive Substances During Containment Linked to COVID-19
An observational study of People Incarcerated and COVID-19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020. On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- People Incarcerated, COVID-19
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 1 Aug 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: People incarcerated in Villeneuve-Lès-Maguelon prison
Who may be able to join
- Men incarcerated at Villeneuve Les Maguelone prison
- On a given date (May 12)
- Major
- French speaking
- non illiterate
Who cannot join
- minors
- patients refusing
- non-French speaking
- illiterate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in the Consumption of Psychoactive Substances by People Incarcerated at the Villeneuve-Lès-Maguelone Prison During Containment Linked to COVID-19.
The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020.
On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17, including suspension of visiting rooms and activities in detention.
Read more
Containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, PTSD, depression, suicide, addictive behavior and violence.
However,prisoners have a higher prevalence of substance use disorders than the general population.
What will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the Villeneuve Les Maguelone prison.
- Anonymous questionnaire from the start
- Collection of socio-demographic data
- Collection of consumption data before and during containment
- Collection of monitoring data
- Conditions
- People Incarcerated, COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage changes in the consumption of psychoactive substances
percentage changes in the consumption of psychoactive substances
Measured: 1 day
Secondary outcomes (3)
Assessment of the level of stress
Assessment of the level of stress by self-administered questionnaire before / during confinement
Measured: 1 day
Assessment of depression
Assessment of depression by self-administered questionnaire before / during confinement
Measured: 1 day
Craving modification evaluation
Craving modification evaluation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 May 2020
- Primary completion30 May 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People IncarceratedStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie Mieuset, PhD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380714
- Sponsor's protocol ID
- RECHMPL20_0273
- Status last verified
- Dec 2020
- First submitted
- 7 May 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Consumption of Psychoactive Substances by People Incarcerated at the Villeneuve-Lès-Maguelone Prison During Containment Linked to COVID-19.
- ClinicalTrials.gov ID
- NCT04380714
- Acronym / sponsor ID
- RECHMPL20_0273
- Conditions
- People Incarcerated, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 8 May 2020 (actual)
- 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.
The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020.
On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17, including suspension of visiting rooms and activities in detention.
Containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, PTSD, depression, suicide, addictive behavior and violence.
However,prisoners have a higher prevalence of substance use disorders than the general population.
What will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the Villeneuve Les Maguelone prison.
- Anonymous questionnaire from the start
- Collection of socio-demographic data
- Collection of consumption data before and during containment
- Collection of monitoring data
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People incarcerated in Villeneuve-Lès-Maguelon prison
Key inclusion criteria (5 listed)
- Men incarcerated at Villeneuve Les Maguelone prison
- On a given date (May 12)
- Major
- French speaking
- non illiterate
Key exclusion criteria (4 listed)
- minors
- patients refusing
- non-French speaking
- illiterate
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
percentage changes in the consumption of psychoactive substances
Time frame: 1 day
percentage changes in the consumption of psychoactive substances
3 secondary outcomes
Assessment of the level of stress
Time frame: 1 day
Assessment of depression
Time frame: 1 day
Craving modification evaluation
Time frame: 1 day
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 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Aurélie Mieuset, PhD principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of People Incarcerated and COVID-19, run by University Hospital, Montpellier at 1 site 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 5 inclusion and 4 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 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
percentage changes in the consumption of psychoactive substances (time frame: 1 day). 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 Dec 2020.